Manufacturer
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.GLAM LED Facial Mask (TB-2386F)
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K251727
- Device name
- GLAM LED Facial Mask (TB-2386F)
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2025-06-05
- Decision date
- 2025-08-29
- Submission type
- Traditional
- Technology type
- LED(AI inferred)
- Clinical applications
- Skin tighteningAcne treatmentOther
- Primary application
- Acne treatment
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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 Facial Mask (Model: TB-2386F) is a Class II powered laser surgical instrument that operates using light emitting diodes (LEDs) to produce bands of light for the treatment of full-face wrinkles and mild to moderate acne of the face. The device emits specified wavelengths and operates in a 15-minute cycle before automatically deactivating.
Summary parsed at:2026-06-01 05:23:28 UTC