Who is the manufacturer of Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)?

Shenzhen Aozemei Technology Co., Ltd. filed the 510(k) submission for Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) (K243430).

What is the FDA product code for Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)?

NFO. It is classified under 21 CFR 882.5890 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)?

2 Face / Face Evolution (K171821); Micro-current vibration facial cold and hot service Model: TPML-100 (K213039); BEAGANK 4T PLUS (K233010).

Who can help prepare an FDA 510(k) submission like Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)

K243430 · Shenzhen Aozemei Technology Co., Ltd. · NFO · Dec 19, 2024 · Neurology

Device Facts

Record ID	K243430
Device Name	Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
Applicant	Shenzhen Aozemei Technology Co., Ltd.
Product Code	NFO · Neurology
Decision Date	Dec 19, 2024
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.5890
Device Class	Class 2
Attributes	Therapeutic

Intended Use

Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. (cleared under K241718) Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation.

Device Story

Handheld, portable, battery-operated device for home aesthetic use. Features two electrode massage heads for micro-current stimulation, a motor for vibration, and LED arrays (amber, red, blue). User operates device to apply stimulation, vibration, and light therapy to facial and neck skin. Micro-current function uses biphasic pulsed square waveforms to provide electrical stimulation. LED modes provide specific wavelengths (amber 605nm, red 630nm, blue 415nm) for skin treatment. Device includes a heating element for thermal comfort (40±1℃). Output is controlled by internal software. Benefits include potential reduction of wrinkles and acne through non-invasive stimulation and light therapy. Healthcare providers do not operate the device; it is for patient self-use.

Clinical Evidence

Bench testing only. No clinical data provided. Biocompatibility testing performed per ISO 10993-5, -10, and -23. Electrical safety and electromagnetic compatibility verified per IEC 60601-1, 60601-1-2, 60601-1-11, and 60601-2-10. Battery safety verified per IEC 62133-2.

Technological Characteristics

Handheld device constructed of ABS and PC. Features two electrode massage heads. Energy source: internal 3.7V rechargeable lithium battery, charged via Type-C cable. Stimulation: biphasic pulsed square wave (57Hz, 4ms pulse width). LED wavelengths: 415nm (blue), 605nm (amber), 630nm (red). Thermal output: 40±1℃. Software-controlled operation. Biocompatibility per ISO 10993. Electrical safety per IEC 60601 series.

Indications for Use

Indicated for treatment of facial wrinkles and mild to moderate inflammatory acne in adults seeking over-the-counter aesthetic facial and neck stimulation.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

2 Face / Face Evolution (K171821)
Micro-current vibration facial cold and hot service Model: TPML-100 (K213039)
BEAGANK 4T PLUS (K233010)

Related Devices

K213039 — Micro-current facial cold and hot service (model: TPML-100) · Li-Tek Electronics Technology C0., Ltd. · May 25, 2022
K252146 — Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209) · Shenzhen Siken 3D Technology Development Co., Ltd. · Dec 23, 2025
K253833 — Facial & Body Beauty Device (model: INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) · Shenzhen Jianchao Intelligent Technology Co., Ltd. · Jan 30, 2026
K162652 — Smart Photon Micro-current Device, Model: EP-300 · Li-Tek Electronic Technology Corporation · Oct 25, 2017
K241718 — Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) · Shenzhen Aozemei Technology Co., Ltd. · Oct 28, 2024

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a smaller font. December 19, 2024 Shenzhen Aozemei Technology Co. Ltd Riley Chen RA Specialist Feiying Drug & Medical Consulting Technical Service Group Rm 2401 Zhenye International Business Center, No. 3101-90 Qianhai Road Shenzhen, Guangdong 518052 China Re: K243430 Trade/Device Name: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: November 5, 2024 Received: November 5, 2024 Dear Riley Chen: We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register. {1}------------------------------------------------ Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality System (OS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-device-advicecomprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatory {2}------------------------------------------------ assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, # Heather L. Dean -S Heather Dean, PhD Assistant Director, Acute Injury Devices Team DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health {3}------------------------------------------------ ## Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below. Submission Number (if known) K243430 Device Name Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) Indications for Use (Describe) Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. (cleared under K241718) Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation. Type of Use (Select one or both, as applicable) Prescription Use (Part 21 CFR 801 Subpart D) X | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {4}------------------------------------------------ # 510(k) Summary ### "510(k) Summary" as required by 21 CFR Part 807.92. #### I. Submitter Company name: Shenzhen Aozemei Technology Co., LTD Address: 3/F, Building 9, Tianfu'an Industrial Park, lezhujiao, Huangmabu Community, Hangcheng Street, Baoan District, Shenzhen, Guangdong, China Contact person: Zemin Wu Title: General Manager Tel.: +86-150 1922 0323 Email: 80728261@gq.com Date: 2024.11.5 #### II. Subject Device Name of Device: Micro-current Facial Beauty Device Model(s): AM-810W, AM-810B, AM-812W, AM-812B Common or Usual Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NFO Regulation Number: 21 CFR 882.5890 #### III. Predicate Device | No. | Manufacturer | Device name | Product code | 510(k) Number | Cleared Date | |-----|--------------------------------------------|------------------------------------------------------------------------------|---------------|---------------|----------------| | 1. | Heat In A Click | 2 Face / Face Evolution | NFO, OHS, OLP | K171821 | April 26, 2018 | | 2. | Li-Tek Electronics Technology Co., Ltd. | Micro-current vibration facial cold and hot service Model: TPML-100 | NFO, OLP | K213039 | May 25, 2022 | | 3. | BELEGA Co., Ltd. | BEAGANK 4T PLUS | NFO | K233010 | Nov. 21, 2023 | #### IV. Device Description The Micro-current Facial Beauty Device is a portable, non-sterile, reusable device designed to achieve the aesthetic effect. It consists of main unit, charging cable, cleaning flannelette, storage bag, instrument base and user manual. The device is supplied by internal rechargeable lithium battery, which can be recharged by external charger through the Type-C charging cable. The device is un-usable when charging. The device is only home environment use, which has two massage heads, and three LED light mode (Amber/ Red/ Blue lights are output independently) to provides following functions: {5}------------------------------------------------ - a. Amber, Red and Blue LED irradiation function. The device outputs amber light with the wavelength of 605±10nm, and red light with the wavelength of 630±10mm. It is used to illuminate facial skin with narrow spectral bandwidth light and treat facial wrinkles. Also, it outputs blue light with the wavelength of 415±10nm and is used to illuminate facial skin with narrow spectral bandwidth light and treat mild to moderate inflammatory acne. (Cleared under K241718) - b. Hot compress and vibration function. The device generates different intensity of vibration by a builtin motor to relax the facial skin, and also, the massage head is heated to 40±1℃, making the facial skin feel warm to relax and soothe the facial skin. (The vibration is classified as class I and not need for 510K, and the hot compress is not for medical purpose). (Cleared under K241718) - c. MS-Micro current stimulation function. The device has two electrode massage heads to do facial stimulation. #### V. Indications for Use Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne. (cleared under K241718) Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation. #### VI. Comparison of Technological Characteristics With the Predicate Device The Micro-current Facial Beauty Device has the same intended use as the predicates. The technological characteristics, features, specifications, materials are similar to the predicate devices. Any minor differences between the subject device and the listed predicate devices do no raise any issues of safety or efficacy. Performance data supports that the device is safe and as effective as the predicate devices for its intended use. Therefore, the Micro-current Facial Beauty Device may be found substantially equivalent to its predicate devices. {6}------------------------------------------------ | Elements of Comparison | Subject Device | Primary Predicate Device | Predicate Device 1 | Predicate Device 2 | Remark | |------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------| | Device Name and Model | Micro-current Facial Beauty Device Model: AM-810B, AM- 810W, AM-812B, AM- 812W | 2 Face / Face Evolution | Micro-current vibration facial cold and hot service Model: TPML-100 | BEAGANK 4T PLUS | / | | 510(k) Number | Pending | K171821 | K213039 | K233010 | / | | Product code | NFO | NFO, OHS, OLP | NFO, OLP | NFO | Same | | Device classification | Class II | Class II | Class II | Class II | Same | | OTC or prescription | OTC | OTC | OTC | OTC | Same | | Intended Use | Micro-current Facial Beauty Device is a handheld portable device for over the counter aesthetic use including facial and neck stimulation. | 2 Face / Face Evolution is a hand-held device for over- the counter aesthetic purposes. (1) The EMS mode is indicated for facial stimulation; (2) The Photon mode: The red light is intended for the treatment of periorbital wrinkles and the blue light is intended for the treatment of the mild to moderate inflammatory acne. | Micro-current facial cold and hot service is an over the counter device that is indicated for the treatment of mild to moderate inflammatory acne and facial stimulation for the over the counter aesthetic use. | The BEAGANK 4T PLUS is a handheld portable device for overthe-counter aesthetic use including facial and neck stimulation. | Same | | Elements of Comparison | Subject Device | Primary Predicate Device | Predicate Device 1 | Predicate Device 2 | Remark | | Dimensions | AM-810B, AM-810W: 135*85*39mm AM-812B, AM-812W: 110*92*68mm | 158mm*56mm*51.5mm | 188(L)×50(W)×55(H)mm | / | Different | | Weight | AM-810B, AM-810W: 118g AM-812B, AM-812W: 130g | 200g | 233g | 136g | | | Treatment area | Face and neck | Entire Face | Facial skin | Facial and neck or body skin | Same | | Software control | YES | YES | YES | YES | Same | | Handheld | YES | YES | YES | YES | Same | | Power source | Adapter input: 5V=0.5A Internal battery: 3.7V/600mAh | DC 3.7V 2200mAh | Charger (not included) input: DC 5V, 1A Internal battery: 3.7Vd.c. 900mAh | Internal rechargeable Lithium-ion battery | Similar | | Battery | Lithium battery | Battery | Lithium battery | Lithium battery | Same | | Micro-current Stimulation Function | | | | | | | Waveform Type | Biphasic pulsed square | Pulsed Biphasic, Modulated | Bi-phase square-wave pulse | Rectangle, biphasic | Same | | Elements of Comparison | Subject Device | Primary Predicate Device | Predicate Device 1 | Predicate Device 2 | Remark | | wave | Square | | asymmetric | | | | Maximum Output Voltage | 225mV @500Ω 900mV @2kΩ 3.60V @10kΩ | 310mV @ 500Ω 1.16V @ 2kΩ 5.56V @ 10kΩ | 225 mV @500Ω, ±10% 900 mV @2kΩ, ±10% 3.86 V @10kΩ, ±10% | Mode 1: 127mV@500Ω, ±15% 515mV@2kΩ, ±15% 1.83V@10kΩ, ±15% | Similar | | Maximum Output Current | 450μA @500Ω 450μA @2kΩ 360μA @10kΩ | 620μA @ 500Ω 580μA @ 2kΩ 556μA @ 10kΩ | 450 μA @500Ω, ±10% 450 μA @2kΩ, ±10% 386 μA @10kΩ, ±10% | Mode 1: 0.19mA@500Ω,±15% 0.18mA@2kΩ, ±15% 0.16mA@10kΩ,±15% | | | Pulse Width | 4ms | 60ms | 4ms | Mode 1: 265µs | Same | | Output Frequency | 57Hz | 8.333Hz | 57±3Hz | Mode 1: 3.80kHz | Same | | Net charge | 0 µC @ 500Ω | | 0 µC @ 500Ω | Mode 1: 0.025µC | Same | | Maximum Current Density | AM-810B, AM-810W: 0.10mA/cm²@500Ω AM-812B, AM-812W: 0.06mA/cm²@500Ω | 0.330mA/cm² @500 Ω (The Minimum Electrode Size: 2.91cm²) | 0.49mA/cm²@500Ω | Mode 1: Standard:0.15mA/cm² Scalp: 0.53mA/cm² | Similar | | Elements of Comparison | Subject Device | Primary Predicate Device | Predicate Device 1 | Predicate Device 2 | Remark | | Maximum Power Density | AM-810B, AM-810W: $0.0117mW/cm^2@500Ω$ AM-812B, AM-812W: $0.0072mW/cm^2@500Ω$ | $4.34µW/cm^2 @500Ω$ (The Minimum Electrode Size: $2.91cm^2$ ) | $0.20mW/cm^2@ 500Ω$ | Small: $1.36mA/cm^2$ Mode 1: $8.51μW/cm^2$ With a wet cotton pad $11.39μW/cm^2$ | | | Treatment frequency | • MS-Micro current stimulation mode: It is recommended to use the product 10-15 minutes at a time / 2-3 times a week. | EMS Mode (5 minutes) Photon Mode (5~7 minutes) | Hold treatment face in contact with skin. Apply blue light for 3minutes per skin area, followed by red light for 3 minutes per skin area. Can be used daily. Apply EMS micro-current for 15 minutes per day. Can be used for 2-3 times per week. | 5 minutes | Same | | Main Materials | ABS, PC | ABS Plastic & Stainless Steel | PC, ABS, Stainless steel (SUS 304) | ABS | Different, but solved by biocompatibility test | {7}------------------------------------------------ {8}------------------------------------------------ {9}------------------------------------------------ {10}------------------------------------------------ #### VII.Performance Data The following performance data were provided in support of the substantial equivalence determination. #### 1) Biocompatibility Testing The biocompatibility evaluation for the body-contacting components of the Micro-current Facial Beauty Device was conducted in accordance with the "Use of International Standard ISO 10993-1. 'Biological Evaluation of Medical Devices -Part 1: Evaluation and Testing Within a Risk Management Process, Document Issued on September 4, 2020", as recognized by FDA. The following testing was performed to, and passed, including: - > ISO 10993-5: 2009, Biological evaluation of medical devices -Par t 5: Tests for in vitro cytotoxicity - > ISO 10993-10: 2021, Biological evaluation of medical devices Part 10: Tests for skin sensitization - > ISO 10993-23: 2021, Biological evaluation of medical devices Part 23: Tests for irritation #### 2) Electrical Safety - > IEC 60601-1 Medical electrical equipment Part 1: General requirements for basic safety and essential performance - > IEC 60601-1-2 Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances -Requirements and tests - > IEC 60601-1-11 Medical Electrical Equipment -Part 1-11: General Requirements for Basic Safety and Essential Performance -Collateral Standard: Requirements for Medical Electrical Equipment and Medical Electrical Systems Used in the Home Healthcare Environment - > IEC 60601-2-10 Medical electrical equipment Part 2-10: Particular requirements for the basic safety and essential performance of nerve and muscle stimulators - > IEC 62133-2, Secondary cells and batteries containing alkaline or other non-acid electrolytes -Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems #### 4) Software Verification and Validation Software documentation consistent with Basic Documentation Level of concern was submitted in this 510(k). System validation testing presented in this 510(k) demonstrated that all software requirement specifications are met and all software hazards have been mitigated to acceptable risk levels. #### VIII. Conclusions Based on the above analysis and non-clinical tests performed, it can be concluded that the subject device is as safe, as effective, and performs as well as the legally marketed predicate devices.