(117 days)
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.
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.
The provided text is a 510(k) Summary for the Skin Care Beauty Mask (Model: MJ-06), which is a premarket notification to the FDA for demonstrating substantial equivalence to a legally marketed predicate device. This document focuses on demonstrating that the new device is as safe and effective as existing products, rather than proving a novel clinical benefit through extensive clinical studies with acceptance criteria and statistical analysis.
Therefore, the requested information regarding detailed acceptance criteria, specific study designs (like MRMC or standalone performance), sample sizes for test and training sets, expert qualifications, and ground truth establishment, is largely not present within this type of regulatory submission.
The "Test Summary" section primarily refers to bench testing against recognized safety and performance standards, not clinical trials to measure effectiveness against specific numerical acceptance criteria for clinical outcomes. The FDA clearance is based on substantial equivalence to a predicate device (K202390), indicating that its technological characteristics and intended use are similar enough not to raise new questions of safety or effectiveness.
Here's a breakdown of what can be extracted and what is missing, based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
Not applicable in the typical sense of clinical performance acceptance criteria. The "acceptance criteria" here are compliance with recognized electrical safety, EMC, and biocompatibility standards, and demonstrating substantial equivalence to a predicate device in terms of design, function, and intended use. The table below reflects the comparison to the predicate device and the standards met.
| Element of Comparison / Standard | Acceptance Criteria (Implicit: Similar to Predicate / Compliance with Standard) | Reported Device Performance |
|---|---|---|
| Intended Use / Indications for Use | To treat full face wrinkles and/or mild to moderate acne (similar to predicate) | 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. SE to predicate. |
| Wavelengths | Red: 640nm±10nm, Blue: 465nm±10nm (similar to predicate) | Red: 640nm±10nm, Blue: 465nm±10nm. SE to predicate. |
| Power Density | 30mW/cm² (similar to predicate) | 30mW/cm². SE to predicate. |
| Treatment Time | 5 or 10 minutes/day, 3 times per week (similar functionality to predicate) | 5 or 10 minutes/day, 3 times per week. SE to predicate. |
| Safety and EMC | Compliance with listed IEC/ANSI standards | Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-57. SE to predicate. |
| Biocompatibility | Compliance with listed ISO standards | Complies with ISO 10993-1, ISO 10993-5, ISO 10993-10. SE to predicate. |
| Overall Conclusion | Does not raise new types of questions of safety or effectiveness compared to predicate | Performance testing supports safe and effective use. Substantially equivalent to predicate K202390. |
2. Sample Size for the Test Set and Data Provenance
- Sample Size for Test Set: Not mentioned. The document primarily refers to "lab bench testing" (Section 6) against recognized standards and a comparison to a predicate device. There is no indication of a clinical "test set" with human subjects specifically for evaluating the effectiveness of the MJ-06 model in a clinical trial setting to establish new performance claims.
- Data Provenance: The document does not specify country of origin for any clinical data because detailed clinical performance data in a trial setting is not provided. It mentions the manufacturer as Shenzhen Kaiyan Medical Co Ltd, China, and a distributor in Denver, CO, USA. The "Test Summary" only lists engineering and biocompatibility standards.
3. Number of Experts Used to Establish Ground Truth and Qualifications
- Not applicable. This information would be relevant for clinical studies where expert consensus or diagnostic interpretation is needed to establish ground truth for a test set. This document relies on compliance with engineering standards and comparison to a previously cleared device.
4. Adjudication Method for the Test Set
- Not applicable. As no clinical test set requiring expert adjudication is described, this information is not present.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
- No. An MRMC study is a type of clinical study assessing diagnostic performance, usually comparing human readers with and without AI assistance. This document is a 510(k) submission for a physical light therapy device, not a diagnostic AI algorithm, and does not mention any such study.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a physical light therapy mask, not an algorithm.
7. The Type of Ground Truth Used
- For the technical and biocompatibility testing, the "ground truth" is compliance with the specified international standards (e.g., IEC 60601 series for electrical safety, ISO 10993 series for biocompatibility).
- For the overarching claim of effectiveness, the "ground truth" is established by the predicate device's prior clearance by the FDA for similar indications. The current device demonstrates substantial equivalence to this predicate.
8. The Sample Size for the Training Set
- Not applicable. This information is relevant for AI/machine learning models. The device is a hardware light therapy system.
9. How the Ground Truth for the Training Set was Established
- Not applicable.
In summary: The provided 510(k) summary is a regulatory document focused on demonstrating equivalency to a predicate device and adherence to safety standards. It does not contain the detailed clinical study data typically associated with a novel device proving its effectiveness against specific clinical acceptance criteria. The FDA's clearance (K220168) is based on the argument that the device is "substantially equivalent" to an already approved device (K202390) and meets relevant safety standards, meaning it does not raise new questions of safety or effectiveness.
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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.
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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
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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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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
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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 AAMIES60601-1 | Medical electrical equipment - Part 1:General requirements for basic safety andessential performance | 2005/(R)2012 andA1:2012,C1:2009/(R)2012 andA2:2010/(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 andessential performance - CollateralStandard: Requirements for medicalelectrical equipment and medical electricalsystems used in the home healthcareenvironment | Edition 2.0 2015-01 | 06/27/2016 |
| IEC 60601-2-57 | Medical Electrical Equipment - Part 2-57:Particular requirements for the basic safetyand essential performance of non-laserlight source equipment intended fortherapeutic, diagnostic, monitoring andcosmetic/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 andessential performance - CollateralStandard: 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 skinsensitization | 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
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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 ofComparison | 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 | -- |
| ClassificationName | Over-The-Counter PoweredLight Based Laser For Acne (OLP), Light Based Over-TheCounter Wrinkle Reduction (OHS) | Over-The-Counter Powered LightBased Laser For Acne (OLP), LightBased OverThe Counter WrinkleReduction (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 inthe red and blue region of thespectrum, specifically indicatedto treat full face wrinkles and/ormild 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 redand blue region of the spectrum,specifically indicated to treat fullface wrinkles and/or mild tomoderate acne. | SE |
| Wavelengths | Red: 640nm±10nmBlue: 465nm±10nm | Red: 640nm±10nmBlue: 465nm±10nm | SE |
| Power supply | Adapter:Input: 100-240Va.c., 50/60Hz,0.5AOutput: 5.0Vd.c., 2.0A | For model MK-660, MK-66USBO:3.7Vdc 2600mAh Lithium batteryAdapter for charging only:Input: 100- 240Vac;Output: 5Vdc, 2A.For model MK-020: 3.7Vdc2600mAh 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 ofComparison | Subject Device | Predicate Device | Remark |
| week | |||
| Power Density(mw/cm²) | 30mW/cm² | 30mW/cm² | SE |
| Location for Use | Face | Face | SE |
| Environment ofUse | OTC | OTC | SE |
| Safety and EMC | IEC 60601-1IEC 60601-1-2IE C60601-1-11IEC 60601-2-57 | IEC 60601-1IEC 60601-1-2IE C60601-1-11IEC 60601-2-57 | SE |
| Biocompatibility | ISO 10993-1ISO 10993-5ISO 10993-10 | ISO 10993-1ISO 10993-5ISO 10993-10 | SE |
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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.
9. Date prepared: May 2022
§ 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.