LED Light Therapy Mask (2311, 2344, 2457, 2458)— 510(k) K252189

Name: FDA 510(k) clearance K252189
Creator: U.S. Food and Drug Administration
Published: 2025-09-12

Substantially Equivalent

Dongguan Yanxi Technology Co., Ltd.

FDA 510(k) clearance K252189 for LED Light Therapy Mask (2311, 2344, 2457, 2458), Substantially Equivalent on 2025-09-12. Applicant: Dongguan Yanxi Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Dongguan Yanxi Technology Co., Ltd.
Product code: Code OHS
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2025-07-14
Decision date: 2025-09-12
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.