# K252994: LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)

- Pathway: 510(k) (Traditional)
- Applicant: Guangdong Ace-Tec Co., Ltd.
- Decided: Dec 8, 2025 after 81 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). 284 ancestors in all.
No later device cites it as a predicate yet.
0 of 285 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242796: CryoGlow (FW3XXXX), Sharkninja Operating, LLC (2024) Summary page 5.
- K231555: LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189)), iSMART Developments, Ltd. (2023) Summary page 5.
- K240089: Face Patches (MT-12MA, MT-12MC), Shenzhen Kaiyan Medical Equipment Co., Ltd. (2024) Summary page 5.

## Indications for use
ACNE mode (red light + blue light): Treatment of mild to moderate inflammatory acne. FIRM mode (yellow light): Treatment of full-face wrinkles. WRINKLE mode (red light + IR light): Treatment of full-face wrinkles.

Source page: https://510kreport.com/device/K252994
Methodology: https://510kreport.com/methodology