(136 days)
No
The device description details standard functions like LED light therapy, hot compress, and vibration, with no mention of adaptive algorithms, data processing for decision making, or any terms associated with AI/ML. The performance studies focus on safety and electrical standards, not AI/ML validation.
Yes
The device is intended for the treatment of facial wrinkles and mild to moderate inflammatory acne, which are therapeutic indications.
No
Explanation: A diagnostic device is used to detect, diagnose, treat, or prevent disease. This device is intended for the treatment of facial wrinkles and mild to moderate inflammatory acne, which are therapeutic rather than diagnostic purposes.
No
The device description explicitly states it consists of a "main unit, charging cable, cleaning flannelette, storage bag, instrument base and user manual," and describes hardware components like massage heads, LED lights, a built-in motor, and a rechargeable battery. This indicates it is a physical device with integrated software, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Micro-current Facial Beauty Device is a physical device that applies micro-currents, LED light, heat, and vibration directly to the skin's surface. It does not analyze any biological samples.
- Intended Use: The intended use is for the treatment of facial wrinkles and acne, which are conditions treated topically or with physical modalities, not through the analysis of biological samples.
Therefore, the device's function and intended use clearly fall outside the scope of In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne.
Product codes
OHS, OLP
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:
- 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.
- 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 class I and not need for 510K, and the hot compress is not for medical purpose).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face
Indicated Patient Age Range
Not Found
Intended User / Care Setting
home environment use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
The following performance data were provided in support of the substantial equivalence determination.
- 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.
- Electrical Safety: IEC 60601-1:2005/AMD1:2012/AMD2:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance; IEC 60601-1-2:2014+A1:2020 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 :2015/AMD1:2020 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 60601-2-83:2019 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment; IEC 62133-2:2017, 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.
- Eye Safety: IEC 62471:2006 Photobiological safety of lamps and lamp systems.
- Software Verification and Validation: Software documentation consistent with moderate 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.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.
(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.
0
Image /page/0/Picture/2 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 28, 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: K241718
Trade/Device Name: Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W) Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: OHS OLP Dated: June 11, 2024 Received: June 14, 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
1
Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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 (QS) 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.
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-regulatoryassistance/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.
Yan Fu -S
Digitally signed by Yan Fu
Date: 2024.10.28 15:23:56
-04'00'
2
for
Tanisha Hithe Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K241718
Device Name
Micro-current Facial Beauty Device (Model(s): AM-810B, AM-810B, AM-812W, AM-812B)
Indications for Use (Describe)
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne.
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)
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4
510(k) Summary - K241718
"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@qq.com Date: 2024.10.10
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: Over-The-Counter Powered Light Based Laser For Acne Light based over the counter wrinkle reduction Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: II Product Code: OHS, OLP Regulation Number: 21 CFR 878.4810
III. Predicate Device and Reference Device
-
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. | Galactic Beauty, LLC | MMSphereTM | OHS, OLP | K190443 | Jun. 24, 2019 |
| 3. | Shenzhen SUNGPO HI-TECH Electronic Co., Ltd | LED Facial Mask | OHS, OLP | K230351 | May 5, 2023 |
> Reference Device
| No. | Manufacturer | Device name | Product code | 510(k) Number | Cleared Date |
|---|---|---|---|---|---|
| 1. | STG24 CO.,LTD. | LED | |||
| MASK | |||||
| EXCLUSIVE MD | OHS, OLP | K232795 | Dec. 7, 2023 |
IV. Device Description
5
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:
- 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.
- 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 class I and not need for 510K, and the hot compress is not for medical purpose).
V. Indications for Use
Micro-current Facial Beauty Device is intended for the treatment of facial wrinkles, and mild to moderate inflammatory acne.
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 | Reference Device | Remark |
|---|---|---|---|---|---|---|
| Device Name | ||||||
| and Model | Micro-current Facial | |||||
| Beauty Device | ||||||
| Model: AM-810B, AM- | ||||||
| 810W, AM-812B, AM- | ||||||
| 812W | 2 Face / Face Evolution | MMSphereTM | LED Facial Mask/ MZ- | |||
| 01, NEWKEY-01, SP- | ||||||
| FM-01 | LED MASK | |||||
| EXCLUSIVE MD | ||||||
| Model: ME-M20M4 | / | |||||
| 510(k) Number | K241718 | K171821 | K190443 | K230351 | K232795 | / |
| Regulation | ||||||
| number | 878.4810 | 882.5890, 878.4810 | 878.4810 | 878.4810 | 878.4810 | Same |
| Product code | OHS, OLP | NFO, OHS, OLP | OHS, OLP | OHS, OLP | OHS, OLP | Same |
| Intended Use | Micro-current Facial | |||||
| Beauty Device is intended | ||||||
| for the treatment of facial | ||||||
| wrinkles, and mild to | ||||||
| moderate inflammatory | ||||||
| acne. | 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. | MMSphereTM | |||||
| Therapy Device emits | ||||||
| energy in the red, blue | ||||||
| and amber regions of the | ||||||
| spectrum, specifically | ||||||
| indicated to treat wrinkles | ||||||
| and/or mild to moderate | ||||||
| acne. The MMSphereTM | ||||||
| is designed to be used for | ||||||
| 20 minute treatments | ||||||
| three to seven times per | ||||||
| week. | Light LED Facial Mask is an | |||||
| over the counter device | ||||||
| that is intended to use | ||||||
| the LED light for the | ||||||
| treatment of wrinkles | ||||||
| and mild to moderate | ||||||
| acne | LED MASK EXCLUSIVE | |||||
| MD is an over the counter | ||||||
| device that is indicated for | ||||||
| the treatment of full face | ||||||
| wrinkles with red light and | ||||||
| infrared light and treat | ||||||
| mild to moderate acne | ||||||
| vulgaris of the face. | Same | |||||
| Treatment area | Face | Entire Face | Facial skin | Face | Face | Same |
| Elements of | ||||||
| Comparison | Subject Device | Primary Predicate Device | Predicate Device 1 | Predicate Device 2 | Reference Device | Remark |
| Software control | YES | YES | YES | YES | Yes | Same |
| Handheld | YES | YES | Handheld and stationary | No | No, mask type | Same |
| Power source | Adapter input: 5V=0.5A | |||||
| Internal battery: | ||||||
| 3.7V/600mAh | DC 3.7V 2200mAh | / | An external adapter | |||
| Input: AC 100-240V, | ||||||
| 50-60Hz 0.2A | ||||||
| Output: DC 12V 0.5A | / | Similar | ||||
| Battery | Lithium battery | Battery | Lithium battery | / | Battery | Same |
| Light Therapy Function | ||||||
| Light source | Light Emitting Diodes | |||||
| (LED) | LED | Light Emitting Diodes | ||||
| (LED) | Light Emitting Diodes | |||||
| (LEDs) | LED | Same | ||||
| Wavelength | 415±10nm blue light | |||||
| 605±10nm amber light | ||||||
| 630±10nm red light | Red Light: 630nm±3nm | |||||
| Blue Light: 415nm±3nm | 605nm, 625nm, 465nm | Blue: 465nm±5nm | ||||
| Red: 625nm±5nm | ||||||
| Amber: 605nm±5nm | 415nm | |||||
| 655nm | ||||||
| 845nm | Same | |||||
| Elements of | ||||||
| Comparison | Subject Device | Primary Predicate Device | Predicate Device 1 | Predicate Device 2 | Reference Device | Remark |
| Irradiance | ||||||
| (mW/cm²) | Red light: 2.5mW/cm² | |||||
| Amber light: 15mW/cm² | ||||||
| Blue light: 1.4mW/cm² | Red light: 73.26mW/cm²±10% | |||||
| Blue light: 64.10mW/cm²±10% | Red: 2.45 mW/cm² | |||||
| Blue: 1.33 mW/cm² | ||||||
| Amber: Not | ||||||
| publicly available | Blue: 15~63mW/cm² | |||||
| Red: 31~75mW/cm² | ||||||
| Amber: 15~42mW/cm² | - Red: 1mW/cm² + NIR: | |||||
| 1mW/cm² |
- Blue: 1mW/cm² | Similar |
| Main Materials | ABS, PC | ABS Plastic & Stainless Steel | / | ABS and PC plastic | / | Different,
but solved
by
biocompatibility test |
| Biocompatibility | ISO 10993-5
ISO 10993-10
ISO 10993-23 | ISO 10993-5
ISO 10993-10 | Comply with ISO
10993-1 | Comply with
ISO10993-1,
ISO10993-5 and
ISO10993-10 | ISO 10993-5
ISO 10993-10
ISO 10993-11 | Same |
| Electrical safety | IEC 60601-1
IEC 60601-1-2
IEC 60601-1-11
IEC 60601-2-83 | IEC 60601-1
IEC 60601-1-2
IEC60601-2-10
IEC60601-2-57 | ANSI/AAMI ES 60601-1
EN 60601-1-2
IEC 60601-1-11
IEC 60601-2-57 | IEC60601-1-2
IEC60601-1
IEC60601-1-11
IEC60601-2-57 | ES 60601-1
IEC 60601-2-57
IEC 60601-1-11
IEC 60601-1-2 | Same |
7
8
9
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 60601-1:2005/AMD1:2012/AMD2:2020 Medical electrical equipment Part 1: General requirements for basic safety and essential performance
-
IEC 60601-1-2:2014+A1:2020 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 :2015/AMD1:2020 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 60601-2-83:2019 Medical electrical equipment Part 2-83: Particular requirements for the basic safety and essential performance of home light therapy equipment
-
IEC 62133-2:2017, 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
3) Eye Safety
-
IEC 62471:2006 Photobiological safety of lamps and lamp systems
4) Software Verification and Validation
Software documentation consistent with moderate 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.