Search Results

The LED Light Therapy Mask (Model: FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.

FCM902, FCM905, FCM906, FCM908:
a.Red light: Treatment of full-face wrinkles.
b.Blue+Infrared light: Treatment of mild to moderate inflammatory acne.
c.Yellow+Infrared light: Treatment of full-face wrinkles.

11-001-RBMASK:
a.Red+Infrared light: Treatment of full-face wrinkles.
b.Blue light: Treatment of mild to moderate inflammatory acne.

FCM910:
a.Red+Infrared light: Treatment of full-face wrinkles.
b.Blue light: Treatment of mild to moderate inflammatory acne.
c.Yellow+Infrared light: Treatment of full-face wrinkles.

The LED Light Therapy Mask (FCM902, FCM905, FCM906, FCM908, 11-001-RBMASK, FCM910) adopts light emitting diodes (LED) in the red (630nm ±5nm) , infrared (880nm±5nm) and blue (415±5nm) spectrum to irradiate on the face to realize its therapeutic effect.

For FCM902, FCM905, FCM906, FCM908 and FCM910, it also contain yellow (590±5nm) spectrum and green (520±5nm) spectrum.

The LED Light Therapy Mask adopts the form of a mask that contains LEDs on the inner surface of the main unit. A controller is connected to the main unit to control the device, such as turn on/off the device, switch mode (LED color). To use the device, user should place the mask over the face and use the controller to operate. The device will automatically turn off after each treatment. To prevent irradiation of LED lights to eyes during the treatment, LED Light Therapy Mask has incorporated protective eye-shield which blocks light energy from LEDs.

a. Red light: Treatment of full-face wrinkles.
b. Blue+Infrared light: Treatment of mild to moderate inflammatory acne.
c. Yellow+Infrared light: Treatment of full-face wrinkles.
d. Green Light: light in wavelength 520nm(±5nm). Green light makes users feel like they are outside in a green world, which may make users relax, which has no medical therapeutic effect.
e. Red+Infrared light: Treatment of full-face wrinkles.
f. Blue light: Treatment of mild to moderate inflammatory acne.

The provided FDA 510(k) Clearance Letter concerns an LED Light Therapy Mask for treating wrinkles and mild to moderate inflammatory acne. However, this document is a clearance letter and a 510(k) summary, not a clinical study report. It primarily focuses on demonstrating substantial equivalence to predicate devices based on technological characteristics and non-clinical testing.

Therefore, the document does NOT contain the details required to answer many of the specific questions about acceptance criteria and the study that proves the device meets those criteria, particularly those related to clinical performance, human reader studies, or expert ground truth.

The information provided is mostly about device specifications, comparison to predicates, and compliance with non-clinical safety standards (electrical safety, biocompatibility, photobiological safety). It states that "Non-clinical testings have been conducted to verify that the LED Light Therapy Mask meets all design specifications which supports the conclusion that it's Substantially Equivalent (SE) to the predicate device."

Based on the provided text, I can only address what is explicitly mentioned or can be reasonably inferred. Most of the questions below would require a separate clinical study report, which is not part of this 510(k) summary.

Acceptance Criteria and Device Performance (Based only on the provided 510(k) Summary):

The acceptance criteria for this device, as inferred from the 510(k) summary, are primarily centered around Substantial Equivalence (SE) to legally marketed predicate devices for the specified indications for use, and compliance with relevant safety and performance standards for an OTC device. The "performance" reported is largely in terms of meeting these technical and safety standards, rather than clinical efficacy metrics from a new human study.

1. Table of Acceptance Criteria and Reported Device Performance

Regarding the study that proves the device meets the acceptance criteria:

Based solely on the provided 510(k) summary, the "study" proving the device meets acceptance criteria appears to be a non-clinical testing program focused on product safety and performance standards for substantial equivalence. There is no mention of a human clinical study, an AI component requiring a test set for diagnostic accuracy, or experts establishing ground truth in a clinical context within this document.

Therefore, I cannot provide answers for many of the following questions as the requested information is not present in the provided text.

2. Sample size used for the test set and the data provenance:

• Not applicable / Not provided. The document describes non-clinical testing of the device itself (electrical, photobiological, biocompatibility, software V&V), not a clinical test set from patients.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

• Not applicable / Not provided. There is no mention of a test set requiring expert-established ground truth for performance evaluation in this 510(k) summary. This typically applies to AI/CADe devices or clinical efficacy studies, neither of which are detailed here.

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

• Not applicable / Not provided. Since no clinical test set or expert ground truth process is described, an adjudication method is irrelevant.

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, not done / Not applicable. This device is an LED light therapy mask, not an AI-assisted diagnostic tool. An MRMC study is completely irrelevant to this type of device and its 510(k) clearance.

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

• Not applicable. There is no "algorithm only" performance study as this is a physical light therapy device, not a diagnostic algorithm.

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

• Not applicable / Not provided for clinical efficacy. For the non-clinical tests, the "ground truth" would be the specified parameters and limits of the IEC/ISO standards (e.g., maximum allowable leakage current, certified photobiological safety levels, biocompatibility thresholds). There is no mention of a clinical ground truth (e.g., for wrinkle reduction or acne treatment) from a study in this document.

8. The sample size for the training set:

• Not applicable / Not provided. This device is cleared based on substantial equivalence and compliance with non-clinical performance standards. It implies a known or existing mechanism of action (light therapy) rather than a newly developed AI algorithm that requires a training set of data.

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

• Not applicable / Not provided. As no training set for an algorithm is mentioned, the method for establishing its ground truth is also not applicable.

Ask a specific question about this device