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510(k) Data Aggregation
(85 days)
GLAM LED Facial Mask (TB-2386F)
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.
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.
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 70% of subjects reporting improvement) in overall skin appearance, texture, or satisfaction as reported by subjects via a validated questionnaire. |
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