VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES— 510(k) K063396

Substantially Equivalent

Lasering S.R.L.

FDA 510(k) clearance K063396 for VELURE FAMILY OF DIODE LASERS AND DELIVERY DEVICE ACCESSORIES, Substantially Equivalent on 2007-01-17. Applicant: Lasering S.R.L..

Clearance details

Applicant: Lasering S.R.L.
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2006-11-09
Decision date: 2007-01-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Ramon, 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.