W.O.M. LASER U100PLUS— 510(k) K032023

Substantially Equivalent

W.O.M. World of Medicine AG

FDA 510(k) clearance K032023 for W.O.M. LASER U100PLUS, Substantially Equivalent on 2003-10-01. Applicant: W.O.M. World of Medicine AG.

Clearance details

Applicant: W.O.M. World of Medicine AG
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2003-06-30
Decision date: 2003-10-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Alexandria, VA, 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.