510(k) K132613— SONILASE LIGHT THERAPY DEVICE

Substantially Equivalent

Biorenew Labs, LLC

Clearance details

Applicant: Biorenew Labs, LLC
Product code: Code OHS
Advisory panel: General, Plastic Surgery
Date received: 2013-08-21
Decision date: 2014-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Coralville, IA, US

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.