(117 days)
Not Found
No
The device description focuses on the physical components and light wavelengths used for treatment, with no mention of AI or ML capabilities. The "Mentions AI, DNN, or ML" section is explicitly marked as "Not Found".
Yes
The device is intended to treat full face wrinkles and mild to moderate acne, which are therapeutic indications. Furthermore, it explicitly refers to IEC 60601-2-57, which covers "non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use."
No
Explanation: The device description and intended use clearly state that the Skin Care Beauty Mask is designed to "treat full face wrinkles and/or mild to moderate acne" and "improve the appearance of wrinkles," respectively. It functions by emitting light to achieve these therapeutic and cosmetic effects, not to diagnose any condition.
No
The device description clearly states it is a "facemask-shaped device" that "makes use of specific light spectral characteristics and directly applies light onto the face skin surface," indicating it is a physical hardware device with integrated LED lights. The performance studies also include testing against hardware safety standards (e.g., IEC 60601 series).
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The Skin Care Beauty Mask (Model: MJ-06) is a light therapy device that applies light directly to the skin surface. It does not involve the collection or analysis of any biological specimens.
- Intended Use: The intended use is to treat full face wrinkles and/or mild to moderate acne by applying light energy to the skin. This is a therapeutic application, not a diagnostic one.
The information provided clearly describes a device that interacts directly with the body's surface for therapeutic purposes, which is not the function of an IVD.
N/A
Intended Use / Indications for Use
The Skin Care Beauty Mask (Model: MJ-06) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne.
Product codes
OHS, OLP
Device Description
The Skin Care Beauty Mask (Model: MJ-06) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies light onto the face skin surface. The Skin Care Beauty Mask can emit two different kinds of wavelengths. The blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) is intended to improve the appearance of wrinkles. There are 150 LED lights with a center wavelength of 465nm and 150 LED lights with a center wavelength of 640nm, and the energy provided by each mode is 30mw/cm2 . The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 5-minute treatment or 10-minute treatment selected.
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
Over-The-Counter 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
Skin Care Beauty Mask (Model: MJ-06) has been evaluated the safety and performance by lab bench testing as following:
Standards No. ANSI AAMI ES60601-1, Standard Title Medical electrical equipment - Part 1: General requirements for basic safety and essential performance, Version 2005/(R)2012 and A1:2012, C1:2009/(R)2012 and A2:2010/(R)2012, Date 07/09/2014.
Standards No. IEC 60601-1-11, Standard Title 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, Version Edition 2.0 2015-01, Date 06/27/2016.
Standards No. IEC 60601-2-57, Standard Title Medical Electrical Equipment - Part 2-57: Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use, Version Edition 1.0 2011-01, Date 03/16/2012.
Standards No. IEC 60601-1-2, Standard Title Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests, Version Edition 4.0 2014-02, Date 09/17/2018.
Standards No. ISO 10993-5, Standard Title Biological evaluation of medical devices - Part 5: Tests for in vitro cytotoxicity, Version Third edition 2009-06-01, Date 12/23/2016.
Standards No. ISO 10993-10, Standard Title Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization, Version Third Edition 2010-08-01, Date 07/26/2016.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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/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 and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
May 17, 2022
Shenzhen Kaiyan Medical Co Ltd Alain Dijkstra CEO 40A Fuxin Road Fuyong Subdistrict BaoAn District, Shenzhen, Guangdong 518101 China
Re: K220168
Trade/Device Name: Skin Care Beauty Mask (Model: MJ-06) 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: January 17, 2022 Received: January 20, 2022
Dear Alain Dijkstra:
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 (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 located 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
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 803) for devices or postmarketing safety reporting (21 CFR 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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 mediation-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,
Purva Pandya Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K220168
Device Name Skin Care Beauty Mask (Model: MJ-06)
Indications for Use (Describe)
The Skin Care Beauty Mask (Model: MI-06) emits energy in the region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate 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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3
510(k) Summary of K220168
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 878.4810.
1. Submitter's Information
Company Name: SHENZHEN KAIYAN MEDICAL CO LTD Address: 40A Fuxin Road Fuyong Subdistrict BaoAn District Shenzhen, Guangdong, China Contact Person (including title): Alain Dijkstra (CEO) Tel: +86 755 82129361 E-mail: regulation@kaiyanmedical.com
Distributor
Company Name: GODDESS'S MESSENGER LTD Address: 1624 Market St Ste 226, #79525 Denver CO 80202 USA Phone: +86 17310376031
Application Correspondent:
Contact Person: Alain Dijkstra Company: SHENZHEN KAIYAN MEDICAL CO LTD Address: 40A Fuxin Road Fuyong Subdistrict BaoAn District Shenzhen, Guangdong, China Tel: +86 755 82129361 Email: regulation@kaiyanmedical.com
2. Subject Device Information
Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over-The Counter Wrinkle Reduction (OHS) Trade Name: Skin Care Beauty Mask Model Name: MJ-06 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 878.4810 Regulatory Class: II
3. Predicate Device Information
Sponsor: SHENZHEN KAIYAN MEDICAL CO LTD
4
K220168
Trade Name: Aduro Light Beauty Mask, MK-660, MK-66USBO, MK-66USBA, MK-66USBB, MK-020, MK-02A, MK-02B Classification Name: Over-The-Counter Powered Light Based Laser For Acne (OLP), Light Based Over-The Counter Wrinkle Reduction (OHS) 510(K) Number: K202390 Review Panel: General & Plastic Surgery Product Code: OHS, OLP Regulation Number: 878.4810 Regulation Class: II
4. Device Description
The Skin Care Beauty Mask (Model: MJ-06) is a facemask-shaped device, which makes use of specific light spectral characteristics and directly applies light onto the face skin surface. The Skin Care Beauty Mask can emit two different kinds of wavelengths. The blue light (465nm) is intended to help reduce the appearance of mild to moderate inflammatory acne. Red light (640nm) is intended to improve the appearance of wrinkles. There are 150 LED lights with a center wavelength of 465nm and 150 LED lights with a center wavelength of 640nm, and the energy provided by each mode is 30mw/cm2 . The user wears the mask on their face for the treatment, and the device will shut down automatically after finishing a 5-minute treatment or 10-minute treatment selected.
5. Intended Use / Indications for Use
The Skin Care Beauty Mask (Model: MJ-06) emits energy in the red and blue region of the spectrum, specifically indicated to treat full face wrinkles and/or mild to moderate acne.
6. Test Summary
Skin Care Beauty Mask (Model: MJ-06) has been evaluated the safety and performance by lab bench testing as following:
| Standards No. | Standard Title | Version | Date |
|---|---|---|---|
| ANSI AAMI | |||
| ES60601-1 | Medical electrical equipment - Part 1: | ||
| General requirements for basic safety and | |||
| essential performance | 2005/(R)2012 and | ||
| A1:2012, | |||
| C1:2009/(R)2012 and | |||
| A2:2010/(R)2012 | 07/09/2014 | ||
| Standards No. | Standard Title | Version | Date |
| 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 | Edition 2.0 2015-01 | 06/27/2016 | |
| IEC 60601-2-57 | Medical Electrical Equipment - Part 2-57: | ||
| Particular requirements for the basic safety | |||
| and essential performance of non-laser | |||
| light source equipment intended for | |||
| therapeutic, diagnostic, monitoring and | |||
| cosmetic/aesthetic use | Edition 1.0 2011-01 | 03/16/2012 | |
| 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 | Edition 4.0 2014-02 | 09/17/2018 | |
| ISO 10993-5 | Biological evaluation of medical devices - | ||
| Part 5: Tests for in vitro cytotoxicity | Third edition 2009- | ||
| 06-01 | 12/23/2016 | ||
| ISO 10993-10 | Biological evaluation of medical devices - | ||
| Part 10: Tests for irritation and skin | |||
| sensitization | Third Edition 2010- | ||
| 08-01 | 07/26/2016 |
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K220168
7. Comparison to predicate device and conclusion
The subject device is very similar in design principle, indications for use, functions, materials, and applicable performance, when compared to the above models of the K202390 predicate. Differences
6
K220168
between the subject device and predicate do not raise new types of questions with regard to the safety and effectiveness of the subject device for the proposed indications for use.
| Elements of
| Comparison | Subject Device | Predicate Device | Remark |
|---|---|---|---|
| Company | SHENZHEN KAIYAN MEDICAL CO LTD | SHENZHEN KAIYAN MEDICAL CO LTD | -- |
| Trade Name | Skin Care Beauty Mask | Aduro Light Beauty Mask | -- |
| Classification | |||
| Name | Over-The-Counter Powered | ||
| Light Based Laser For Acne (OLP), Light Based Over-The | |||
| Counter Wrinkle Reduction (OHS) | Over-The-Counter Powered Light | ||
| Based Laser For Acne (OLP), Light | |||
| Based OverThe Counter Wrinkle | |||
| Reduction (OHS) | -- | ||
| 510(k) Number | K220168 | K202390 | -- |
| Product Code | OHS, OLP | OHS, OLP | SE |
| Intended Use / | |||
| Indications for Use | The Skin Care Beauty Mask | ||
| (Model: MJ-06) emits energy in | |||
| the red and blue region of the | |||
| spectrum, specifically indicated | |||
| to treat full face wrinkles and/or | |||
| mild to moderate acne. | For MK-660, MK-66USBO, MK- | ||
| 020: | |||
| The Aduro Light Beauty Mask | |||
| (Model: MK-660, MK-66USBO, | |||
| MK-02O) emits energy in the red | |||
| and blue region of the spectrum, | |||
| specifically indicated to treat full | |||
| face wrinkles and/or mild to | |||
| moderate acne. | SE | ||
| Wavelengths | Red: 640nm±10nm | ||
| Blue: 465nm±10nm | Red: 640nm±10nm | ||
| Blue: 465nm±10nm | SE | ||
| Power supply | Adapter: | ||
| Input: 100-240Va.c., 50/60Hz, | |||
| 0.5A | |||
| Output: 5.0Vd.c., 2.0A | For model MK-660, MK-66USBO: | ||
| 3.7Vdc 2600mAh Lithium battery | |||
| Adapter for charging only: | |||
| Input: 100- 240Vac; | |||
| Output: 5Vdc, 2A. | |||
| For model MK-020: 3.7Vdc | |||
| 2600mAh Lithium battery | SE | ||
| Irradiance source | LEDs | LEDs | SE |
| Treatment time | 5 or 10 minutes/day, 3 times per | 10minutes/day, 3 times per week | SE |
| Elements of | |||
| Comparison | Subject Device | Predicate Device | Remark |
| week | |||
| Power Density | |||
| (mw/cm²) | 30mW/cm² | 30mW/cm² | SE |
| Location for Use | Face | Face | SE |
| Environment of | |||
| Use | OTC | OTC | SE |
| Safety and EMC | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IE C60601-1-11 | |||
| IEC 60601-2-57 | IEC 60601-1 | ||
| IEC 60601-1-2 | |||
| IE C60601-1-11 | |||
| IEC 60601-2-57 | SE | ||
| Biocompatibility | ISO 10993-1 | ||
| ISO 10993-5 | |||
| ISO 10993-10 | ISO 10993-1 | ||
| ISO 10993-5 | |||
| ISO 10993-10 | SE |
7
8. Conclusion:
The proposed device utilizes the same technological characteristics as the above listed model configurations of K202390, and is also for use in the treatment of mild to moderate acne and treatment of wrinkles. After an analysis of the proposed device's design, functionality, safety, materials, and performance testing results, the sponsor believes that the device's technology does not raise new types of questions regarding safety and efficacy of the subject device for the proposed indications, and performance testing supports that the device can be used safely and effectively. The subject device Skin Care Beauty Mask (Model: MJ-06) is considered to substantially equivalent to the above-specified devices of K202390.