LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8)— 510(k) K252994

Name: FDA 510(k) clearance K252994
Creator: U.S. Food and Drug Administration
Published: 2025-12-08

Substantially Equivalent

Guangdong Ace-Tec Co., Ltd.

FDA 510(k) clearance K252994 for LED Therapy Mask (SR11CM, SR11CM1, SR11CM2, SR11CM3, SR11CM4, SR11CM5, SR11CM6, SR11CM7, SR11CM8), Substantially Equivalent on 2025-12-08. Applicant: Guangdong Ace-Tec Co., Ltd.. Device class: 2.

Clearance details

Applicant: Guangdong Ace-Tec Co., Ltd.
Product code: Code OHS
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2025-09-18
Decision date: 2025-12-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dongguan, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code OHS

view all

K261602 — Eye Recovery Pro (PH-e03)2026-08-10
K261601 — LED Light Therapy Mask (M01, M02, M03, M05, M06, M07, M08)2026-08-07
K261496 — LED Light Therapy Masks (PE748, PE749, PE756)2026-08-04
K261851 — LED Light Therapy Mask (5 models)2026-08-04
K261482 — LightStim for Wrinkles (1984); LightStim for Acne (2038)2026-07-31

Adverse events under product code OHS

product code OHS

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.