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

Name: FDA 510(k) clearance K142638
Creator: U.S. Food and Drug Administration
Published: 2014-12-19

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. Device class: 2.

Clearance details

Applicant: Innovaquartz, LLC
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
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 ↗

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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.