# K250830: LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Sungrow Led Technology Co., Ltd.
- Decided: Jun 9, 2025 after 82 days
- Product code: OHS (Light Based Over The Counter Wrinkle Reduction)
- 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Indications for use
Red light: Treatment of full-face wrinkles. Yellow light: Treatment of full-face wrinkles. Red+Infrared light: Treatment of full-face wrinkles. Blue light: Treatment of mild to moderate inflammatory acne. Mixed light (Red+Blue+Infrared): Treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K250830
Methodology: https://510kreport.com/methodology