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

Substantially Equivalent

Shenzhen Saidi Light Therapy Technology Co., Ltd.

Clearance details

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

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.