LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W)— 510(k) K253400

Name: FDA 510(k) clearance K253400
Creator: U.S. Food and Drug Administration
Published: 2025-12-24

Substantially Equivalent

Shenzhen Saidi Light Therapy Technology Co., Ltd.

FDA 510(k) clearance K253400 for LED Light Therapy Face Mask (FM60X, FM60X-B, FM60X-W, FM80-W, FM80, VAP1, FM100X, FM100X-B, FM100X-W), Substantially Equivalent on 2025-12-24. Applicant: Shenzhen Saidi Light Therapy Technology Co., Ltd.. Device class: 2.

Clearance details

Applicant: Shenzhen Saidi Light Therapy Technology Co., Ltd.
Product code: Code OHS
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2025-09-30
Decision date: 2025-12-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Shenzhen, CN

Download summary PDF View on FDA.gov ↗

Recent devices under product code OHS

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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.