FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

LED Light Therapy Mask is a home use wearable LED phototherapy device which can help reduce facial wrinkles and mild to moderate inflammatory acne. LED Light Therapy Mask is consisting of main unit (mask), controller, Type-C charging cable and so on. There are 4 kinds of light, including Red light (wavelength 630nm), Blue light (wavelength 415nm), Amber light (wavelength 605nm), Infrared light (wavelength 850nm).

The M01, M02, M06, M07, M08 output 4 kinds of treatment modes: red+infrared, red, amber, blue. The M09 outputs 3 kinds of treatment modes: red+infrared, amber, blue+red+infrared.

AI/ML Overview

This FDA 510(k) clearance letter does not describe a study that proves the device meets acceptance criteria. Rather, it indicates clearance due to substantial equivalence to predicate devices based on non-clinical testing.

Here's a breakdown of why the requested information cannot be provided from the given document:

No Clinical Study Details: The document explicitly states "Non-Clinical and/or Clinical Tests Summary & Conclusions (21 CFR 807.92(b))" and then lists only non-clinical tests (ISO 10993-1, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-83, IEC 62471). There is no mention of any clinical study, patient data, ground truth establishment, or expert reviews.

Therefore, for your subsequent requests regarding acceptance criteria and a study that proves the device meets them, the following answers are based on the absence of such information in the provided document:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated in the document. The clearance is based on substantial equivalence to predicate devices, implying performance comparable to those devices rather than specific quantitative acceptance criteria for clinical efficacy.
Reported Device Performance: Not reported in clinical terms. The document only references non-clinical testing for safety and electrical performance.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable as no clinical study test set is described. The non-clinical tests would have involved specific samples (e.g., device units, materials for biocompatibility) but these are not "test sets" in the context of clinical performance evaluation.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable as no clinical study with a test set requiring ground truth establishment is described.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable as no clinical study with a test set requiring adjudication is described.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

No MRMC comparative effectiveness study was done, nor is there any mention of AI in this device. This is an LED light therapy mask, not an AI diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not applicable as this is an LED light therapy mask, not an algorithm or AI device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable as no clinical study requiring ground truth is described.

8. The sample size for the training set

Not applicable as this is an LED light therapy mask; there is no mention of machine learning or an algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable as this is an LED light therapy mask; there is no mention of machine learning or an algorithm requiring a training set with established ground truth.

Summary of what is contained in the document regarding "proof" of meeting criteria:

The FDA clearance for the LED Light Therapy Mask (K251667) is based on substantial equivalence to legally marketed predicate devices, not on a new clinical study demonstrating specific efficacy or performance criteria. The "proof" provided in the 510(k) summary focuses on non-clinical testing and technological comparisons:

Non-Clinical Testing:
- Biological evaluation (ISO 10993-1:2018)
- Electrical safety (IEC 60601-1:2020)
- Electromagnetic compatibility (IEC 60601-1-2:2020)
- Home healthcare environment requirements (IEC 60601-1-11:2020)
- Specific requirements for home light therapy equipment (IEC 60601-2-83:2022)
- Photobiological safety (IEC 62471:2006)
Technological Comparison (Substantial Equivalence): The device's indications for use, power supply (lithium batteries tested per IEC 62133-2), LED wavelengths (red: 630nm, amber: 605nm, blue: 415nm, infrared: 850nm), irradiance levels, and safety features (Type BF applied part) were found to be similar or within the acceptable range of the predicate and reference devices.

Summary

Regulation Number and Section

§ 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.