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The Red Light is intended to treat full face wrinkles.
The Blue Light is intended to treat mild to moderate inflammatory acne.
The Yellow Light is intended to treat wrinkles.

Device Description

The GLAM LED light therapy mask is a home use 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 and mild to moderate acne of the face. The outer shell of the mask is manufactured from Polyethylene terephthalate (PET). The inner shell is a clear Polycarbonate (PC). The Light emitting diodes are mounted behind the clear Polycarbonate. The LEDs generate the light. The ear hooks are made of Acrylonitrile butadiene styrene (ABS) and the silicone goggle protect the eyes from LED lights. Unfold the ear hooks and place the mask on your face, the mask will automatically activate the light therapy mode. The LEDs produce blue, red and yellow light in the visible spectrum (Blue:415nm +/- 10nm, Yellow: 590nm +/-10nm, Red: 625nm +/-10nm.). The device works by emitting the specified wavelengths to treat full face of wrinkles or to treat mild to moderate inflammatory acne. Press the touch switch on the right ear hook twice to select the light therapy mode you want to use. Each mode operates in a 15-minute cycle. After 15 minutes, the device automatically deactivates the light mode and enters the standby mode.

AI/ML Overview

This FDA 510(k) clearance letter for the GLAM LED Facial Mask (TB-2386F) does not include any information regarding clinical testing, acceptance criteria for device performance related to efficacy (e.g., wrinkle reduction or acne treatment), or studies comparing the device's performance against such criteria.

The letter focuses on the substantial equivalence based on:

Technological Comparison: Comparing light wavelengths, power density, and treatment time to predicates.
Safety Standards Compliance: Verification through non-clinical tests (electrical safety, EMC, biocompatibility, photobiological safety, software verification).

Therefore, I cannot provide details on the specific acceptance criteria for efficacy or a study proving the device meets those criteria from the provided document. The 510(k) summary explicitly states: "No animal or clinical study is included in this submission."

However, if we were to hypothesize what acceptance criteria and a study might look like for a device with these indications, and then illustrate what would be missing from this document:

Hypothetical Acceptance Criteria and Performance Study (Not Found in Provided Document):

Since the provided document explicitly states no clinical study was included, the following tables and sections represent what would typically be expected for a device claiming therapeutic efficacy, but none of this information is present in the provided 510(k) clearance letter.

Hypothetical Acceptance Criteria and Reported Device Performance (If Clinical Data Existed)

Acceptance Criteria (Hypothetical)	Reported Device Performance (Hypothetical)
Red Light (Wrinkle Treatment):
Primary Endpoint: A statistically significant reduction (e.g., >20%) in the appearance of fine lines and wrinkles (e.g., Fitzpatrick Wrinkle Scale, or qualitative dermatological grading) across the full face after 8-12 weeks of treatment, compared to baseline or a control group.	Not reported in 510(k) letter. If available, this section would state the measured percentage reduction in wrinkles, p-values, confidence intervals, and the specific grading scale used. Example: "Mean reduction of 32% in Fitzpatrick Wrinkle Scale scores for fine lines after 10 weeks (p < 0.001, 95% CI: 28-36%)."
Secondary Endpoint (e.g., Patient Satisfaction): A statistically significant improvement (e.g., >70% of subjects reporting improvement) in overall skin appearance, texture, or satisfaction as reported by subjects via a validated questionnaire.	Not reported in 510(k) letter. If available, this would include the percentage of satisfied subjects and questionnaire scores. Example: "85% of subjects reported 'moderate' or 'significant' improvement in overall skin appearance (p < 0.001)."
Blue Light (Mild to Moderate Inflammatory Acne Treatment):
Primary Endpoint: A statistically significant reduction (e.g., >40%) in the mean number of inflammatory acne lesions (papules, pustules, nodules) on the face after 8-12 weeks of treatment, compared to baseline or a control group.	Not reported in 510(k) letter. If available, this would state the measured percentage reduction in lesion count, p-values, and confidence intervals. Example: "Mean reduction of 55% in inflammatory lesion count after 10 weeks (p < 0.001, 95% CI: 50-60%)."
Secondary Endpoint (Investigator Global Assessment - IGA): A statistically significant improvement (e.g., at least a 2-point reduction on a 5-point IGA scale) in at least 70% of subjects.	Not reported in 510(k) letter. If available, this would specify the percentage of subjects achieving the IGA improvement. Example: "75% of subjects achieved at least a 2-point reduction on the IGA scale (p < 0.001)."
Yellow Light (Wrinkle Treatment):
Primary Endpoint & Secondary Endpoint: Mirroring the Red Light criteria for wrinkle treatment, demonstrating similar statistically significant reductions or improvements.	Not reported in 510(k) letter. Similar to Red Light, specific efficacy metrics for wrinkle reduction with Yellow Light would be presented here. Example: "Mean reduction of 28% in Fitzpatrick Wrinkle Scale scores for fine lines after 10 weeks (p < 0.001, 95% CI: 24-32%)."
Safety Endpoints (Common to all lights):
No serious adverse events (SAEs) related to device use. Incidence of treatment-related adverse events (AEs) such as erythema, dryness, or irritation below a pre-defined threshold (e.g., <10% for mild, <1% for moderate/severe).	Only general safety compliance (IEC standards, biocompatibility) is reported in the 510(k) letter. If clinical data existed, this would list observed AEs. Example: "No SAEs reported. Mild, transient erythema observed in 5% of subjects, resolving within 24 hours. No moderate or severe AEs."

Details of the Hypothetical Study (Assuming Clinical Data Existed)

As stated, the provided 510(k) summary explicitly states "No animal or clinical study is included in this submission." Therefore, the following are hypothetical details of what such a study would entail, not actual data from this submission.

Sample Size and Data Provenance (Hypothetical):
- Sample Size: (e.g., N=150 subjects for efficacy assessment, randomly allocated to device treatment and control groups)
- Data Provenance: (e.g., Prospective, multicenter clinical study conducted in the USA.)
Number of Experts and Qualifications for Ground Truth (Hypothetical):
- Number of Experts: (e.g., 3 independent, board-certified dermatologists)
- Qualifications: (e.g., Each dermatologist with at least 10 years of experience in aesthetic dermatology and clinical trials, trained on the specific grading scales used.)
Adjudication Method (Hypothetical):
- (e.g., 2+1 consensus: Two experts independently assessed each subject's condition. If their scores differed, a third, senior dermatologist reviewed the case to reach a consensus score. If 2 of 3 agreed, that was the final consensus.)
Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study (Hypothetical):
- Not Applicable: For a direct-to-consumer LED mask, an MRMC study comparing human readers (e.g., radiologists interpreting images) is not relevant. The device directly treats the skin, and efficacy is assessed via clinical observation/photography and patient self-assessment.
Standalone Performance (Algorithm Only) (Hypothetical):
- Not Applicable: This device is a physical light therapy device, not an AI software algorithm (unless there was a sophisticated integrated diagnostic AI, which is not indicated here). Its "performance" would be its direct therapeutic effect, not an algorithmic output that requires standalone evaluation.
Type of Ground Truth Used (Hypothetical):
- (e.g., Expert Clinical Assessment: Standardized clinical photography, physical examination by dermatologists using validated scales (e.g., Fitzpatrick Wrinkle Scale for wrinkles, inflammatory lesion counts for acne, Investigator Global Assessment (IGA) for overall severity), and patient-reported outcomes via validated questionnaires.)
Sample Size for the Training Set (Hypothetical):
- Not Applicable: Since no AI/ML algorithm requiring a training set is mentioned or implied for efficacy assessment in the 510(k) summary, this concept does not apply here. The device's "training" for efficacy would be its clinical development and demonstration through clinical trials.
How Ground Truth for the Training Set Was Established (Hypothetical):
- Not Applicable: As above, no training set for an algorithm is relevant to the information provided. If it were a predictive AI device, the ground truth would typically be established by expert consensus (e.g., multiple dermatologists labeling images) or by linking imaging data to ground truth data (e.g., biopsy results for skin conditions).

In summary, the provided 510(k) clearance documentation for the GLAM LED Facial Mask focuses solely on the device's substantial equivalence in design, technology, and safety compliance according to international standards for electrical safety, EMC, biocompatibility, and photobiological safety. It explicitly states that no clinical or animal studies were included in the submission to demonstrate efficacy for its intended uses (wrinkle reduction and acne treatment). The FDA cleared this device based on its similarity to previously cleared predicate devices and its adherence to safety standards, implying that its efficacy is presumed to be similar to those predicates without requiring new clinical proof for this specific submission.

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