ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES— 510(k) K080463

Substantially Equivalent

Alma Lasers , Ltd.

FDA 510(k) clearance K080463 for ALMA LASERS THERMOXEL CO2 LASER SYSTEM AND DELIVERY DEVICE ACCESSORIES, Substantially Equivalent on 2008-07-23. Applicant: Alma Lasers , Ltd..

Clearance details

Applicant: Alma Lasers , Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2008-02-20
Decision date: 2008-07-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasanton, 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.