C02 LASER MULTIPULSE— 510(k) K002032

Substantially Equivalent

Asclepion-Meditec AG

FDA 510(k) clearance K002032 for C02 LASER MULTIPULSE, Substantially Equivalent on 2000-09-11. Applicant: Asclepion-Meditec AG.

Clearance details

Applicant: Asclepion-Meditec AG
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2000-07-03
Decision date: 2000-09-11
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Irvine, CA, US

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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.