(140 days)
The LED Light Therapy Mask (Model:MK66R-B) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.
The LED LIGHT THERAPY MASK is a home wearable light-emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles. The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of sillcone. The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The LED LIGHT THERAPY MASK cannot be operated while charging. The controller switches the LEDs ON/OFF and controls power to the mask. The device does not have an adapter, please use adapters of the following specifications: input: 100-240Va.c., 50Hz/60Hz, output: DC 5V, 2A. The device produces red and near infra-red (NIR) light in the visible spectrum (Red: 630+/-5nm, NIR: 830nm) in intended to improve the appearance of wrinkles. The controller switches the LEDs ON/OFF and controls power to the mask. And the cable for connecting with the controller is non-detachable.
This document describes the premarket notification (510(k)) for the LED Light Therapy Mask (Model: MK66R-B) for treating full-face wrinkles. The notification asserts its substantial equivalence to the predicate device, FaceLITE (K191629).
Here's an analysis based on the provided information:
1. Table of Acceptance Criteria & Reported Device Performance
The acceptance criteria are primarily based on compliance with various international standards for medical electrical equipment and photobiological safety. The device performance is consistently reported as "Pass" for all tests.
| Title of the Test | Test Standards / Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General requirements for basic safety and essential performance | IEC 60601-1:2005+A1:2012+A2:2020 Edition: 3.2 2020-08. Test result is within the test acceptance range of the standard. | Pass |
| Electromagnetic disturbances | IEC 60601-1-2:2014+A1:2020 Edition: 4.0 2020-09. No degradation of performance found during test or lower than limits of measurement. | Pass |
| Basic safety and performance requirements for home healthcare environment | IEC 60601-1-11:2015+A1:2020 Edition: 2.0 2020-07. The device operates normally, and can provide basic safety and essential performance. | Pass |
| Particular requirements for the basic safety and essential performance of non-laser light source equipment intended for therapeutic, diagnostic, monitoring and cosmetic/aesthetic use | IEC 60601-2-57 Edition 1.0 2011-01. The test result is within the test acceptance range of the standard. | Pass |
| Photobiological safety of lamps and lamp systems | IEC 62471 First edition 2006-07. The test result is within the test acceptance range of the standard. | Pass |
| Usability Study | IEC 62366-1 Edition 1.0 2015-02 and IEC 60601-1-6 Edition 3.1 2013-10. The subject device can meet the usability goal. | Pass |
| Shelf Life Test | Performance Test (Appearance, Silicone thickness), Key life test, Mask bending test, Plug and pull test, Power Density Test (27 - 33 mW/cm2), Leakage current test (meet IEC 60601-1 clause 8.7.4). | Pass |
| Biocompatibility statement | Materials of Velcro Straps and silicone of mask are identical to previously cleared devices (K202390). | Claimed equivalent |
| Software verification and validation testing | "Moderate" level concern. Documentation provided as recommended by FDA guidance. | Conducted and compliant |
2. Sample Size Used for the Test Set and Data Provenance
The "Test Summary" section refers to "The test sample is the final, finished product of representative model: MK66R-B" for all listed non-clinical performance tests. This indicates that one production-representative unit of the device was used for each of the non-clinical tests (electrical safety, EMC, photobiological safety, usability, and shelf-life).
- Data Provenance: The tests are described as "lab bench testing," and the context is a 510(k) submission, meaning these are internal validation tests conducted by or for the manufacturer (Shenzhen Kaiyan Medical Equipment Co., Ltd) to demonstrate compliance with standards. The geographic origin of the testing lab is not explicitly stated, but the manufacturer is based in China. These are retrospective tests conducted on the device model.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not applicable (N/A) as the study described is a non-clinical performance and safety evaluation, not a clinical study involving human patients or expert interpretation of diagnostic data. The "ground truth" here is defined by compliance with established international safety and performance standards.
4. Adjudication Method for the Test Set
This information is not applicable (N/A) for the same reasons as in point 3. The "adjudication" is essentially whether the device successfully met the objective criteria of the specified test standards.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done
No, a Multi Reader Multi Case (MRMC) comparative effectiveness study was not conducted or reported. The document explicitly states: "Clinical testing was not needed for this 510(k)." Therefore, no effect size of human readers improving with or without AI assistance is provided.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
No, a standalone algorithm-only performance study was not done. This device is a hardware LED light therapy mask, not an AI/software algorithm intended for standalone diagnostic or therapeutic decisions.
7. The Type of Ground Truth Used
For the non-clinical performance testing, the "ground truth" is defined by compliance with recognized international standards (e.g., IEC 60601-1, IEC 60601-1-2, IEC 60601-2-57, IEC 62471, IEC 62366-1) and internal product specifications (e.g., Power Density: 27-33 mW/cm2 for the Shelf Life Test).
8. The Sample Size for the Training Set
This information is not applicable (N/A). This device is a light therapy mask, not a machine learning or AI-powered system that requires a "training set."
9. How the Ground Truth for the Training Set was Established
This information is not applicable (N/A) for the same reason as in point 8.
§ 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.