ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES— 510(k) K103501

Substantially Equivalent

Alma Lasers, Inc.

FDA 510(k) clearance K103501 for ALMA LASERS PIXEL CO2 LASER SYSTEM, DELIVERY DEVICE AND ACCESSORIES, Substantially Equivalent on 2011-01-14. Applicant: Alma Lasers, Inc..

Clearance details

Applicant: Alma Lasers, Inc.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2010-11-29
Decision date: 2011-01-14
Decision: Substantially Equivalent
Clearance type: Special
Location: Buffalo Grove, IL, 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.