ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM— 510(k) K083848

Substantially Equivalent

Alma Lasers , Ltd.

FDA 510(k) clearance K083848 for ALMA LASERS SOPRANO XL MULTI-APPLICATION PLATFORM, Substantially Equivalent on 2009-04-14. Applicant: Alma Lasers , Ltd..

Clearance details

Applicant: Alma Lasers , Ltd.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2008-12-24
Decision date: 2009-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Caesarea, IL

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.