510(k) K221151— Beauty LED Mask, Model: KFB265

Substantially Equivalent

Hunan Guangye Biotechnology Co., Ltd.

Clearance details

Applicant: Hunan Guangye Biotechnology Co., Ltd.
Product code: Code OHS
Advisory panel: General, Plastic Surgery
Date received: 2022-04-20
Decision date: 2022-07-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Changsha City, 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.