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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

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Company

Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
China (CN)

Product code

GEX
21 CFR 878.4810

Predicate devices

2
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Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K251727
Device name
GLAM LED Facial Mask (TB-2386F)
Company
Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
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

Predicate devices

2

K251727 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K251727 as a predicate