# K243492: Ulike Reglow Light Therapy Device (UM10)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Ulike Smart Electronics Co., Ltd.
- Decided: Jan 10, 2025 after 59 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: 18 generations back to K943450 (1995). 289 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 293 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K133896: Rejuvalite MD, Trophy Skin, Inc. (2014) Summary page 6.
- K223544: LED light therapy mask (FM-01, FM-02, FM-03), Guangdong Newdermo Biotech Co., Ltd. (2023) Summary page 6.
- K240089: Face Patches (MT-12MA, MT-12MC), Shenzhen Kaiyan Medical Equipment Co., Ltd. (2024) Summary page 6.

## Most influential descendants
- K254025: LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) (2026), 0 descendants of its own
- K260511: Ulike Reglow Light Therapy Device (UM10) (2026), 0 descendants of its own
- K253054: LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6) (2025), 0 descendants of its own

## 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/K243492
Methodology: https://510kreport.com/methodology