MEGAPULSE LASER SYSTEM AND FIBERS— 510(k) K090776

Substantially Equivalent

Richard Wolf Medical Instruments Corp.

FDA 510(k) clearance K090776 for MEGAPULSE LASER SYSTEM AND FIBERS, Substantially Equivalent on 2009-06-02. Applicant: Richard Wolf Medical Instruments Corp..

Clearance details

Applicant: Richard Wolf Medical Instruments Corp.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2009-03-23
Decision date: 2009-06-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Vernon Hills, IL, 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.