510(k) K254007— LED Light Therapy Silicone Face Mask (kks-225, kks-280, kks-281)

Substantially Equivalent

SZ KKS Silicone&Electronic Co., Ltd.

Clearance details

Applicant: SZ KKS Silicone&Electronic Co., Ltd.
Product code: Code OHS
Advisory panel: General, Plastic Surgery
Date received: 2025-12-15
Decision date: 2026-02-12
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.