AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS— 510(k) K081612

Name: FDA 510(k) clearance K081612
Creator: U.S. Food and Drug Administration
Published: 2008-06-25

Substantially Equivalent

Aesculight, LLC

FDA 510(k) clearance K081612 for AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS, Substantially Equivalent on 2008-06-25. Applicant: Aesculight, LLC. Device class: 2.

Clearance details

Applicant: Aesculight, LLC
Product code: Code GEX
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2008-06-09
Decision date: 2008-06-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woodinville, WA, 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.