510(k) K261052— LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA)

Substantially Equivalent

Guangdong Newdermo Biotech Co., Ltd.

Clearance details

Applicant: Guangdong Newdermo Biotech Co., Ltd.
Product code: Code OHS
Advisory panel: General, Plastic Surgery
Date received: 2026-03-31
Decision date: 2026-06-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Guangzhou, 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.