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Who is ACE-TEC?
ACE-TEC is a China-based National High-Tech Enterprise specializing in the development and manufacturing of home-use beauty devices for global B2B brand partners.

We help beauty brands to turn product concepts into scalable, market-ready devices across facial care, scalp & hair care, and body contouring, supported by fully integrated in-house R&D, engineering, mold development, and mass production capabilities.

Founded in 2008, with manufacturing roots dating back to 2003, ACE-TEC has built long-term OEM/ODM partnerships with international beauty brands through vertically integrated manufacturing and consistent product scalability.

ACE-TEC is the first beauty device manufacturer in China to obtain NMPA Class III medical device registration, setting a regulatory benchmark for the industry. We are also one of the few beauty device manufacturers worldwide with FDA 510(k) clearance.
What does ACE-TEC do?
We engineer and manufacture home-use beauty devices for global brands, covering the full development process from initial concept through industrial design, R&D engineering, mold development, prototyping, and mass production.

We focus exclusively on three categories: facial anti-aging, scalp & hair care, and body contouring, with monthly production capacities of 52,000, 80,000, and 65,000 units respectively.

What truly sets us apart is our Full-Element Vertical Integration System (FEVIS)—an in-house system that brings mold development, injection molding, and final assembly together under one roof. With 80+ R&D engineers and 300+ active patents, we work closely with global beauty brands to turn ideas into manufacturable, scalable products with consistent performance from prototype to production.
What is the background and manufacturing capacity of Guangdong Ace-Tec Co., Ltd. (ACE-TEC) for home-use beauty device OEM/ODM services?

ACE-TEC is a vertically integrated manufacturer specializing in home-use beauty devices, with manufacturing experience dating back to 2003 and ACE-TEC established in 2008. The company supports B2B customers with both existing-product customization and new-product development.

ACE-TEC’s key manufacturing capabilities include industrial design, R&D, tooling, PCBA, injection molding, assembly, testing, reliability verification, and mass production, allowing key development and manufacturing processes to be managed in-house.

Key manufacturing facts:
Manufacturing experience: Since 2003
Factory area: 20,000+ m²
R&D team: 80+ engineers
Patents: 300+
Production lines: 18
Monthly production capacity: 1.2 million+ units
Quality systems: ISO 9001 and ISO 13485
Market certifications: CE, FCC, RoHS, KC, FDA 510(k), and other applicable certifications

This vertically integrated manufacturing structure enables ACE-TEC to support the full product lifecycle—from product concept, design, and engineering to tooling, prototyping, testing, certification, and mass production. ACE-TEC primarily serves brand owners, distributors, and e-commerce companies seeking customized home-use beauty devices or new-product development support.

How should beauty brands choose the right OEM/ODM partnership model with ACE-TEC?

ACE-TEC offers three clear B2B manufacturing models tailored to your brand’s growth stage, R&D budget, and speed-to-market goals—from bespoke joint development to agile private-label customization. Please note: ACE-TEC is a dedicated R&D and manufacturing facility. We do not accommodate personal retail purchases or drop-shipping services. All OEM/ODM projects require a Minimum Order Quantity (MOQ) starting at 1,000 units.

Pathway 1: Full-Scope Turnkey ODM (For Proprietary Engineering & Custom R&D)
Best If: You require complete product differentiation and proprietary hardware IP. You already have a unique product concept or strategy, and you are looking for a highly capable manufacturing partner to execute your vision and bring it to mass production.
Target Scenarios: Global market leaders, established beauty giants, and innovative brands seeking 100% exclusive, proprietary device architectures with strict international regulatory standards.
Key Capabilities & Knowledge Network:
Full-Element Vertical Integration (FEVIS): Our in-house FEVIS system integrates mold design, precision injection molding, and final assembly under one roof, reducing development risk and ensuring 100% consistency from prototype validation to mass production.
Regulatory & Technical Execution: Supported by 80+ in-house engineers and 300+ patents, ACE-TEC helps brands engineer technically differentiated hardware while navigating complex regulatory pathways, including FDA 510(k) and NMPA Class III requirements under strict Non-Disclosure Agreements (NDAs).

Pathway 2: Strategic Co-Creation ODM (For Shared-Investment Development)
Best If: You want exclusive, proprietary beauty devices and are looking for a reliable manufacturing partner to bring your ideas to market, while significantly reducing your upfront R&D and tooling expenses.
Target Scenarios: Regional market leaders, established beauty retail groups, and strong channel operators.
Key Capabilities & Knowledge Network:
Co-Designed Architecture: Leveraging 23+ years of sector expertise, ACE-TEC co-defines product specifications, industrial aesthetics, and ergonomics with your team to ensure precise product-market fit.
Tooling Investment & Market Allocation: ACE-TEC absorbs the primary industrial design, engineering, and mold development costs. In exchange for this zero-tooling-risk model, you receive exclusivity in your primary target markets, while ACE-TEC retains distribution rights in non-competing global regions.

Pathway 3: Private Label & OEM Customization (For Existing Product Models)
Best If: Speed-to-market, validated consumer demand, and minimized product development risks are your top commercial priorities.
Target Scenarios: Amazon sellers, DTC brands, cross-border e-commerce merchants, and private label importers seeking fast commercialization.
Key Capabilities & Knowledge Network:
Market-Tested Product Models: Choose from our mature, mass-production-ready beauty device models developed using real consumer insights. For example, our BCE1 Cellulite Massager achieved over 800,000 units sold in its first year, giving you proven sales potential out of the box.
Quick & Flexible Branding: Easily customize our existing models with your own logo, housing colors, retail packaging, user manuals, and cosmetic details.
Pre-Certified for Fast Market Entry: All base models come pre-certified for major international markets (CE, FCC, PSE, RoHS), eliminating lengthy certification delays so you can start selling right away.

Why do global beauty brands choose ACE-TEC?
Global beauty brands choose ACE-TEC because we help them build more competitive products with less development risk.

Market-driven innovation
Successful products start with market insight, not assumptions. Our dedicated market research and product strategy teams continuously monitor consumer demand, emerging technologies, and category trends to identify real market opportunities. Brands can either co-develop new concepts with us or leverage our validated product platforms, avoiding the time, cost, and uncertainty of developing products from scratch. In 2024, one of our self-developed cellulite massagers generated over USD 800,000 in annual sales.

Patented product development
Every self-developed product is protected by patents, helping brands build differentiated product portfolios, strengthen competitive positioning, and reduce the risk of product imitation.

Full in-house manufacturing system (FEVIS)
From mold development and injection molding to final assembly, every critical manufacturing process is completed in-house. This ensures better control of production, more stable lead times, and consistent quality from prototype to mass production.

Proactive regulatory support
We are the first beauty device manufacturer in China to obtain NMPA Class III medical device registration and one of the few manufacturers globally with FDA 510(k) clearance for selected beauty device categories. Combined with CE, FCC, KC, and other international certifications, plus a dedicated regulatory affairs team that continuously monitors global regulatory changes, we help partners stay ahead of compliance requirements rather than react to them.

Zero-defect quality culture
Quality is built into every stage of development. Through DFMEA, PFMEA, comprehensive reliability testing, and process control, we pursue a zero-defect manufacturing standard to deliver consistent quality at scale.
What makes ACE-TEC one of the top OEM/ODM beauty device manufacturers?

ACE-TEC is a vertically integrated OEM/ODM manufacturer integrating medical-grade aesthetic technology into home-use beauty device development, combining consumer beauty device manufacturing with regulated production capabilities to support global brands across international markets. We operate fully in-house across R&D, industrial design, mold development, electronics, assembly, and testing, ensuring consistent quality and a seamless transition from prototype to mass production without fragmented outsourcing.

Our development system is built on platform-based technologies including RF, EMS, LED light therapy, ultrasound, thermal and cryotherapy, and scalp care systems. This enables brands to build products on mature technology platforms rather than starting from scratch. Supported by 80+ R&D engineers and over 300 patents, we continuously develop new product concepts and support brand differentiation in competitive markets.

We are the first manufacturers in China with NMPA Class III medical device manufacturing capability and FDA 510(k) manufacturing experience for selected product categories, along with CE, FCC, and other international compliance standards, enabling multi-market product launches.

Beyond manufacturing, we serve as a long-term OEM/ODM partner helping global beauty brands accelerate product development, reduce engineering risk, and build scalable product portfolios through a platform-driven and fully controlled manufacturing system.

Do you support signing NDAs?
Yes. We support signing NDAs at the earliest stage of discussion to ensure full protection of product concepts, technical information, and business details before any development begins.
How does ACE-TEC protect intellectual property for OEM/ODM beauty device projects?

ACE-TEC enforces comprehensive legal, operational, and system-level safeguards to protect client intellectual property, proprietary designs, and custom tooling throughout every stage of OEM/ODM beauty device manufacturing.

Key IP protection and governance protocols include:

  • Enforceable NNN Agreements: Supports bilingual (English-Chinese) NNN Agreements (Non-Disclosure, Non-Use, Non-Circumvention) governed by applicable jurisdiction to establish clear legal protections before sensitive CAD files or technical specs are shared.
  • Contractual IP Allocation & Tooling Protection: IP ownership for customer-provided and project-developed assets is explicitly defined contractually prior to project kickoff. Custom tooling funded by clients is dedicated solely to their production, physically tagged, and managed under strict exclusive-use protocols.
  • Vertically Integrated Quality & Security Control: Core engineering and manufacturing processes—including tooling, injection molding, PCBA, and assembly—are managed in-house within our 20,000+ m² facility. This integrated infrastructure ensures end-to-end quality consistency, supply chain agility, and strict internal custody over proprietary product designs.
  • Role-Based Information Governance: Technical documentation and engineering data are managed under role-based access control protocols, ensuring project information is strictly compartmentalized to authorized project personnel.

ISO-Certified Quality Systems: Operating under ISO 13485 and ISO 9001 frameworks, ACE-TEC maintains traceable document controls, supplier confidentiality agreements, and structured system audits to safeguard client assets throughout the project lifecycle.

What is your MOQ and lead time?

Our standard minimum order quantity (MOQ) is 1,000 units per model for OEM/ODM projects.

Lead times are:

Samples: 3–7 business days, depending on the level of customization.

Mass production: 30–45 days after sample approval and order confirmation.

What are your main products?
We develop and manufacture home-use beauty devices across three core categories: facial anti-aging, scalp & hair care, and body contouring, supported by over 23 years of ODM/OEM experience.

Facial anti-aging series: RF devices, LED light therapy masks (FDA 510(k) cleared), EMS lifting devices, Skin care infusion device, Hot and Cold Beauty Device, New Beauty Neck Lifting Device and Skin Tightening Device.

Scalp & hair care series: Hair Straightener Comb, Electric Head Massager, Relaxing Scalp Massager, and Electric Hair Growth Brush.

Body contouring series: EMS Anti Cellulite Device, Body Sculpting Device, EMS Body Massager, and body roller massager.

Our products are powered by multiple core technologies, including RF, EMS, LED light therapy, vacuum suction, microcurrent, electroporation, ultrasound, plasma systems and so on.
Where is ACE-TEC located?

ACE-TEC is located in Dongguan, Guangdong (China), operating a 28,000+ m² manufacturing facility fully equipped with our own in-house mold tooling department, precision injection department, and 18+ production lines.

Logistics & Visit Accessibility:
Airport Access: ~1 hour drive from both Shenzhen Bao’an International Airport (SZX) and Guangzhou Baiyun International Airport (CAN), making on-site factory audits and client visits exceptionally convenient.
Export Hubs: Direct proximity to major shipping ports (Shenzhen Port / Hong Kong Port) ensures efficient, large-scale container freight worldwide.

Does ACE-TEC offer product customization services?
Yes, We provide full-spectrum OEM/ODM customization capabilities, covering everything from visual identity to functional engineering, allowing brands to develop highly differentiated beauty devices.

Brand identity customizationWe support customization of logo, packaging, color, labeling, and user manuals to ensure consistent brand presentation across products and markets.

Industrial design & structural customizationBeyond surface-level changes, we support industrial design and structural modifications, including housing design, ergonomic optimization, and product appearance engineering based on brand positioning and target market needs.

Functional & performance customizationFor ODM projects, we enable deep functional customization, including adjustments to treatment modes, energy levels, system performance, and product operating logic to align with different market requirements.

Product development capabilityFor brands requiring higher differentiation, we also support product development from concept to engineering implementation, ensuring customized solutions can be successfully translated into manufacturable and scalable products.
Can I add my logo and branding to the product?

Yes. We support full branding customization for OEM and ODM projects, including logo printing on the product, packaging customization, color options, and user manual branding.

For most products, we can apply your brand logo using methods such as silk-screen printing, laser engraving, or mold integration depending on the product structure and material. This allows you to launch products under your own brand identity while we handle manufacturing and production. If needed, we can also recommend the most suitable branding method based on your product type and target market.

Can you customize product functions and technologies?

Yes. We provide deep functional and technology customization for ODM projects to help brands develop differentiated beauty devices.

We can adjust and optimize core device parameters based on product positioning and market requirements, including treatment modes, energy levels, intensity settings, timing logic, and user experience design.

For different technology platforms such as RF, EMS, LED light therapy, heating, and microcurrent, we can further customize performance combinations and working sequences to achieve specific treatment effects and target user needs.

Our engineering team works closely with brands to translate functional requirements into stable, manufacturable product solutions that can be scaled for mass production.

We will recommend the most suitable technical configuration based on your product goals and target market.

Can you develop a completely new product from scratch?

Yes — this is our core strength for global beauty brands. Through our Full-Scope Turnkey ODM service, we take your initial concept and turn it into a fully engineered, mass-production-ready, and internationally certified beauty device.

What We Cover (Full-Cycle Engineering):
Market & Product Definition: Data-driven positioning and feature definition.
Industrial & Mechanical Design: Custom ID, ergonomics, and structural engineering.
Electronics & System Architecture: PCB layout, firmware, and thermal/power management.
Prototyping & Validation: Rapid functional samples and rigorous reliability testing.
In-House Tooling & Mass Production: Mold making, precision injection, and assembly across 18+ production lines.
Global Regulatory & Certification: Complete execution for complex compliance pathways, including FDA 510(k) and NMPA Class III medical device standards under strict NDAs.

Why Global Brands Partner with Us:
80+ In-House R&D Engineers & 300+ Active Patents to build strong hardware IP barriers for your brand.
Full-Element Vertical Integration: In-house tooling, precision injection, and 18+ production lines ensure 100% consistency from prototype to mass production.
Single-Source Accountability: You don’t need to coordinate multiple suppliers—we take full responsibility for the entire development process.

Operational Notice: We strictly provide B2B manufacturing for global beauty brands, enterprise clients, and cross-border e-commerce sellers. We do not accommodate personal purchases or drop-shipping. All custom ODM projects require an MOQ starting at 1,000 units.

How should global brands choose between OEM and ODM services for beauty devices?

For most global brands, OEM is the highly recommended choice. OEM (Original Equipment Manufacturing) utilizes ACE-TEC\’s mature technology platforms and existing in-house precision molds, allowing brands to personalize established devices through private labeling, custom colorways, and bespoke packaging. Because the structural and electrical architecture is pre-engineered for turnkey, ready-to-sell market deployment, choosing OEM eliminates upfront mold development fees (NRE), minimizes financial risk, and accelerates time-to-market.

However, if your strategic goal is to build an exclusive product IP from the ground up, ODM (Original Design Manufacturing) is fully supported. This route demands exceptional market foresight regarding product concepts from the brand. Because a complete ODM cycle—from initial custom ID design to tooling and mass production—typically spans 3 to 6 months, brands face severe commercial risks if market trends cool down or competitors launch similar products first. Without sharp insight to validate whether a product concept will remain competitive half a year later, heavy upfront mold investments (NRE) can quickly become sunk costs.

Supported by fully integrated in-house manufacturing—including mold tooling, precision injection, and automated assembly—both paths ensure strict global compliance (CE, FCC, RoHS). Global brands can request pre-bulk sample testing to verify performance before bulk order.

Are your hair care devices suitable for daily use?

Yes 😊 Our hair care devices are designed for regular at-home use as part of a daily or weekly scalp care routine. They are also commonly used in home beauty routines, post-hair wash care, and between salon treatments for maintenance.

What makes them suitable for frequent use is the focus on comfort, safety, and everyday usability:
• Gentle microcurrent stimulation for comfortable scalp contact
• Rounded comb teeth + ergonomic design for a scalp-friendly experience
• Lightweight cordless structure for easy use at home, in the office, or while traveling
• Water-resistant design for convenient use after washing hair

Most users typically use it 3–5 times per week for maintenance, or daily in short sessions depending on scalp condition. It\’s designed to make daily scalp care simple, comfortable, and consistent.

What is RF (Radio Frequency) technology and how does it work?

Radio Frequency (RF) technology uses high-frequency electromagnetic waves to generate controlled heat within the dermal layer of the skin. This thermal effect causes immediate contraction of aged collagen fibers, resulting in a temporary tightening effect, while also stimulating fibroblasts to produce new collagen over time for improved skin firmness and elasticity.

The effectiveness of RF treatment depends on how energy is delivered into the skin. Different RF frequencies determine penetration depth: higher frequencies concentrate energy in more superficial layers, while lower frequencies reach deeper dermal structures. For this reason, advanced RF systems often use frequency modulation technology to achieve more controlled and layered heating rather than relying on a single fixed depth.

The effective temperature range for RF treatment is typically around 41–45°C. Below this range, the thermal stimulation is insufficient; above it, there is a risk of skin discomfort or damage. Therefore, temperature stability and energy control are key factors in RF device performance.

In home-use beauty devices, RF technology is widely used for non-invasive anti-aging treatments, supporting skin tightening, wrinkle reduction, and overall skin texture improvement through consistent and repeated use over time.

What makes RF technology in ACE-TEC devices different from standard RF beauty devices?

The core difference between ACE-TEC’s RF technology and standard RF beauty devices lies in the shift from single-point heating to layered, precision-controlled dermal heating, and from single RF functionality to a multi-technology integrated system designed for full-layer skin coverage.

Frequency Modulation System
The ACE-TEC FBD1 uses a frequency-modulated RF system ranging from 0.67 to 1.45MHz, enabling controlled energy delivery at different penetration depths through frequency switching:

  • 0.67MHz (low frequency): penetrates deeper into the dermis, targeting deeper collagen structures to support skin firmness and address sagging and deeper wrinkles
  • 1.45MHz (mid–high frequency): acts on the upper dermal layer, improving fine lines and overall skin texture
Different frequencies correspond to different penetration depths, allowing a single device to address multi-layer anti-aging needs rather than focusing on a single depth of skin tissue.

Integrated Three-in-One System
FBD1 is built on an integrated R&E three-in-one system architecture, combining RF, EMS, and 630±20nm red light therapy within the same operating mode rather than functioning separately:
  • Modulated RF: provides layered dermal heating to activate collagen remodeling across multiple skin depths
  • EMS (10Hz / 100Hz alternating mode): stimulates facial muscle contractions to support lifting and contour definition. EMS operates simultaneously with RF, meaning muscle activation and thermal collagen contraction occur at the same time, creating a combined “support + lift” effect
  • 630±20nm red light: works concurrently with RF and EMS to support skin recovery and improve overall skin condition and radiance
All three technologies operate simultaneously within a unified system, targeting different layers and structures of the skin to create a multi-layered anti-aging mechanism rather than simple functional stacking.

Intelligent Temperature Control
FBD1 is equipped with an NTC intelligent temperature control system. A built-in NTC thermistor continuously monitors electrode surface temperature in real time. When the temperature reaches 41°C, power output is automatically reduced, and at 42°C, output is paused to maintain operation within a safe thermal range. In home-use RF devices, insufficient temperature results in reduced efficacy, while excessive temperature may increase the risk of burns. The NTC-based closed-loop temperature control system ensures the device operates within an optimal safety and effectiveness window.

Regulatory Recognition
ACE-TEC is the first home-use beauty device manufacturer in China to obtain the NMPA Class III medical device manufacturing license. The FBD1 RF device has also obtained NMPA Class III medical device registration, meaning its safety and performance have been reviewed under the highest regulatory standards by China\’s National Medical Products Administration.

How do RF devices prevent burns?

RF devices generate heat in the dermis layer to stimulate collagen regeneration, but the epidermis has a safe temperature threshold of around 43°C. Exceeding this level may cause skin damage, so temperature control is the core safety mechanism in RF devices.

A safe RF device typically relies on three levels of protection:

  1. Real-time temperature monitoring (hardware level)
    NTC thermal sensors are embedded in the RF handpiece to continuously monitor skin surface temperature in real time.
  2. Intelligent power control (system level)
    When temperature approaches the safety threshold, the system automatically reduces energy output, and further shuts down output if the limit is exceeded.
  3. Multi-layer safety protection (redundancy level)
    Additional protections such as skin contact detection, automatic shut-off when removed from skin, and time-based safety control help prevent overheating in different usage scenarios.

ACE-TEC RF devices (such as the FBD1 RF beauty device) integrate real-time NTC monitoring and multi-level safety control systems to ensure stable energy output within the safe temperature range during use.

How do you ensure consistent product quality?

At ACE-TEC, quality is built into every stage of product development and manufacturing—not just at final inspection.

Our quality management system is certified to ISO 9001 and ISO 13485 and follows a structured quality control process covering the entire product lifecycle. This includes:

  • Design quality planning: DFMEA and PFMEA are applied during product development to identify and reduce potential risks before production begins.
  • Incoming Quality Control (IQC): Critical components such as PCBs, batteries, motors, and electronic parts are inspected before entering production.
  • In-Process Quality Control (IPQC): Key manufacturing processes are monitored throughout production to ensure assembly consistency and process stability.
  • Final Quality Control (FQC) & Outgoing Quality Control (OQC): Every finished product undergoes functional testing, appearance inspection, and safety verification before shipment.
  • Reliability testing: Depending on the product, devices undergo aging tests, high- and low-temperature testing, drop tests, button life tests, waterproof testing, and other reliability evaluations to verify long-term performance.
  • Full traceability: Production records and batch information are maintained throughout the manufacturing process, enabling traceability from raw materials to finished products.

By combining preventive quality planning, in-process control, reliability validation, and full traceability, we ensure consistent product quality from prototype to mass production.

How do you validate beauty devices before market launch?

At ACE-TEC, we ensure product reliability through a prevention-first approach — integrating quality planning and risk control from the design stage, rather than relying only on final product testing.

Our reliability assurance system is built on three key pillars:

  1. Design Risk Prevention
    Before production begins, our engineering and quality teams apply DQA, DFMEA, and PFMEA methods to identify potential design and manufacturing risks early, helping prevent issues before they occur.
  2. Reliability Validation & Testing
    Each product undergoes systematic validation, including functional verification, safety testing, aging tests, high and low temperature tests, drop tests, charging cycle tests, and other product-specific evaluations. Across different product categories, ACE-TEC conducts more than 57 reliability tests to simulate long-term usage conditions.
  3. Manufacturing Validation & Process Control
    Before mass production, pilot production runs are performed to verify process stability and product consistency. Supported by our MES manufacturing system and in-house production capabilities, we ensure a smooth transition from prototype development to scalable production.

Through preventive design, rigorous validation, and controlled manufacturing, ACE-TEC helps global brands reduce product risks and launch reliable beauty devices with confidence.

How do you manage product traceability and continuous quality improvement?

At ACE-TEC, we manage product traceability through a digital manufacturing system integrated with MES and ERP, enabling transparent and controlled production from incoming materials to finished products.

Each production process is recorded through our MES system, with more than 2,000 process parameters collected and monitored daily. Every device is assigned a unique serial number, allowing us to trace its complete manufacturing history, including material batches, production records, inspection results, and key process data.

This device-level traceability allows our team to quickly identify the root cause of any quality deviation, accurately define affected batches, and implement targeted corrective actions when needed.

As an ISO 13485 certified manufacturer, our traceability system follows medical device quality management requirements, supporting two-way traceability from raw materials to finished products and from finished products back to source materials.

Beyond traceability, we continuously improve manufacturing quality through data analysis and CAPA (Corrective and Preventive Action) processes, using production data and quality feedback to optimize processes and prevent recurring issues.

Through digital manufacturing, complete traceability, and continuous improvement systems, ACE-TEC ensures stable quality control and long-term manufacturing reliability for global beauty brands.

Do you provide golden samples for mass production control?

Yes. Golden sample approval is a standard part of ACE-TEC\’s quality launch process to ensure consistency between approved samples and mass production.

Before mass production, we create a golden sample (master sample) as the production reference standard. The sample is reviewed and approved by both ACE-TEC and the brand partner, covering key requirements such as appearance, color, structure, functionality, and packaging.

Once approved, the golden sample becomes the quality benchmark for production. During the first production run, our quality team performs first article inspection (FAI) to verify that mass-produced units match the approved standard before full-scale production begins.

The golden sample is retained throughout the product lifecycle and used together with our in-process quality control (IPQC) system to maintain consistency across future production batches.

Through golden sample approval and controlled production processes, ACE-TEC helps brands ensure that the final products they receive match the quality standard they approved.

What certifications are required to sell beauty devices in the US market?

The regulatory requirements for beauty devices in the US depend on the product\’s intended use, technology, and marketing claims.

For general beauty devices with non-medical purposes, such as cleansing or cosmetic skincare applications, FDA premarket clearance may not be required. However, products still need to comply with applicable safety and compliance requirements.

For devices that make claims affecting the structure or function of the body, or claims related to treating specific conditions (such as acne treatment, wrinkle reduction, or hair growth), the product may be regulated as a medical device. Depending on the device classification, requirements may include:

  • FDA establishment registration and device listing
  • FDA 510(k) clearance or other applicable FDA pathways
  • Quality management system requirements
  • Applicable safety, performance, and biocompatibility testing

Each beauty device requires a regulatory assessment based on its technology, intended use, and product claims.

What certifications are required to sell beauty devices in the Japanese and South Korean markets?

Entering Japan and South Korea requires more than obtaining certificates after production. For beauty devices, compliance should be considered from the early product design stage, including electrical safety, EMC, wireless communication, and battery requirements.

For the Japan market, rechargeable beauty devices typically require compliance with:
PSE requirements under Japan\’s DENAN regulations
TELEC/MIC certification for Bluetooth or wireless-enabled products

For South Korea, products may require:
KC EMC and RF certification for electronic and wireless devices
KC battery safety compliance for lithium battery-powered products

At ACE-TEC, we support brands by integrating compliance considerations into product development. Our R&D and engineering teams evaluate product architecture, components, battery solutions, and testing requirements before mass production to help reduce compliance risks. With ISO 13485 and ISO 9001 quality systems and experience developing beauty devices for global markets, ACE-TEC helps partners prepare products that are ready for Japan, South Korea, and other regulated markets.

What are the European regulatory compliance requirements for home-use beauty devices?

Exporting home-use beauty devices to the EU requires adherence to safety, environmental, and evolving medical device regulations.

CE Marking Compliance
All ACE-TEC devices fully satisfy mandatory EU directives, ensuring seamless market access:

  • EMC Directive (2014/30/EU): Ensures electromagnetic compatibility.
  • Low Voltage Directive (LVD 2014/35/EU): Guarantees electrical and charging safety.
  • RED (Radio Equipment Directive 2014/53/EU): Applies to RF and wireless-enabled units.

RoHS, REACH & EU Battery Regulation
Products comply with RoHS and REACH substance restrictions. To align with the updated EU Battery Regulation, ACE-TEC provides modular architectures featuring user-replaceable batteries, preventing future market access blockages.

Proactive EU MDR (2017/745) Deployment
Operating under an ISO 13485 medical quality system, Guangdong Ace-Tec Co., Ltd. is actively deploying technical documentation for EU MDR (2017/745) compliance. This ensures long-term regulatory protection for brand partners as EU enforcement deadlines approach.

Do you have export qualifications?

Yes 😊 ACE-TEC has full export capability for global markets including Europe, the United States, Japan, and South Korea.

Our products comply with applicable international regulatory requirements such as CE (Europe), FCC (United States), RoHS, as well as market-specific requirements including KC (Korea) and PSE (Japan). For selected product categories, we also have FDA 510(k) regulatory experience for the US market.

What certifications and regulatory compliance capabilities do you have?
ACE-TEC maintains a comprehensive regulatory and compliance system that helps global beauty brands bring products to market with greater confidence and efficiency.

International quality management standards
Our manufacturing system is certified to ISO 9001 and ISO 13485, providing a robust quality management framework for the development and production of home-use beauty devices. For brands developing products with higher quality and regulatory expectations, ISO 13485 supports more standardized development processes, stronger risk management, and greater manufacturing consistency.

Global market access certifications
We support product compliance for major international markets through certifications including CE (Europe), FCC (United States), KC (South Korea), RoHS, CCC, PSE and RoHS compliance, helping brands streamline product registration and accelerate market entry across key global markets.

Advanced regulatory capabilities
ACE-TEC is the first beauty device manufacturer in China to obtain NMPA Class III Medical Device Manufacturing License (License No. 20263090453), meeting one of China’s highest regulatory standards for medical device manufacturing and providing brands with greater confidence when developing products requiring high regulatory compliance. We are also one of the few OEM/ODM beauty device manufacturers globally with FDA 510(k) clearance capability, providing a stronger regulatory foundation for brands planning to enter regulated markets such as the United States.

Proactive regulatory support
Compliance is an ongoing process—not a one-time certification. Our dedicated regulatory affairs team continuously monitors evolving regulatory requirements across the United States, Europe, and Asia, preparing documentation and compliance strategies in advance to help partners stay ahead of regulatory changes, minimize compliance risks, and accelerate product launches.
Does ACE-TEC have FDA 510(k) clearance?

Yes. Guangdong ACE-TEC Co., Ltd. is the FDA 510(k) applicant for K252994, covering its LED Therapy Mask product family (SR11CM and SR11CM1–SR11CM8), with nine models in total.

The device is an OTC, home-use wearable LED phototherapy device. The 510(k) submission includes testing to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 62471, IEC 60601-2-83, IEC 60601-1-6, and ISO 10993-1, covering electrical safety, electromagnetic compatibility, home-use safety, photobiological safety, light therapy equipment, usability, and biocompatibility.

ACE-TEC combines FDA 510(k) experience with ISO 13485, ISO 9001, NMPA Class III manufacturing capabilities, and in-house R&D, engineering, testing, and manufacturing resources for regulated beauty-device projects.

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