# K251727: GLAM LED Facial Mask (TB-2386F)

- Pathway: 510(k) (Traditional)
- Applicant: Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.
- Decided: Aug 29, 2025 after 85 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 21 generations back to K943450 (1995). 313 ancestors in all.
No later device cites it as a predicate yet.
0 of 314 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230293: TheraFace Mask, Therabody, Inc. (2023) Summary page 5.
- K242700: Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B), Shenzhen Nuon Medical Equipment Co., Ltd. (2024) Summary page 5.

## 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.

Source page: https://510kreport.com/device/K251727
Methodology: https://510kreport.com/methodology