SOFTLASE PRO, ORTHOLASE AND HYGIENELASE— 510(k) K091796

Substantially Equivalent

Zap Lasers, LLC

FDA 510(k) clearance K091796 for SOFTLASE PRO, ORTHOLASE AND HYGIENELASE, Substantially Equivalent on 2009-07-31. Applicant: Zap Lasers, LLC.

Clearance details

Applicant: Zap Lasers, LLC
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2009-06-17
Decision date: 2009-07-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasant Hill, CA, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code GEX

product code GEX

Death: 33
Injury: 3,045
Malfunction: 12,903
Other: 25
Total: 16,006

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.