ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273)— 510(k) K142638

Substantially Equivalent

Innovaquartz, LLC

FDA 510(k) clearance K142638 for ProFlex Laser Fibers (ProFlex 200) and ProFlex Laser Fibers (PRoFlex 273), Substantially Equivalent on 2014-12-19. Applicant: Innovaquartz, LLC.

Clearance details

Applicant: Innovaquartz, LLC
Product code: Code GEX
Advisory panel: General, Plastic Surgery
Date received: 2014-09-17
Decision date: 2014-12-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Phoenix, AZ, US

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.