Light Therapy Decollete Mask (1019135)— 510(k) K252096

Substantially Equivalent

Merchsource, LLC

FDA 510(k) clearance K252096 for Light Therapy Decollete Mask (1019135), Substantially Equivalent on 2025-10-01. Applicant: Merchsource, LLC.

Clearance details

Applicant: Merchsource, LLC
Product code: Code OHS
Advisory panel: General, Plastic Surgery
Date received: 2025-07-03
Decision date: 2025-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

Download summary PDF View on FDA.gov ↗

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.