510(k) K250966— CurrentBody Skin LED Light Therapy Mask Series 2 (MK-90H)

Substantially Equivalent

Shenzhen Kaiyan Medical Equipment Co., Ltd.

Clearance details

Applicant: Shenzhen Kaiyan Medical Equipment Co., Ltd.
Product code: Code OHS
Advisory panel: General, Plastic Surgery
Date received: 2025-03-31
Decision date: 2025-06-25
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.