# K260511: Ulike Reglow Light Therapy Device (UM10)

- Pathway: 510(k) (Special)
- Applicant: Shenzhen Ulike Smart Electronics Co., Ltd.
- Decided: Mar 16, 2026 after 27 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
Longest line of descent: 19 generations back to K943450 (1995). 290 ancestors in all.
No later device cites it as a predicate yet.
0 of 291 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K243492: Ulike Reglow Light Therapy Device (UM10), Shenzhen Ulike Smart Electronics Co., Ltd. (2025) Summary page 6.

## Indications for use
Ulike Reglow Light Therapy Device is an over the counter device that is intended for use in the treatment of full face wrinkles and treatment of mild to moderate inflammatory acne.

Source page: https://510kreport.com/device/K260511
Methodology: https://510kreport.com/methodology