1125 XSB XENON FIBER-OPTIC LIGHT SOURCE— 510(k) K052979

Name: FDA 510(k) clearance K052979
Creator: U.S. Food and Drug Administration
Published: 2005-10-31

Substantially Equivalent

Isolux, LLC

FDA 510(k) clearance K052979 for 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE, Substantially Equivalent on 2005-10-31. Applicant: Isolux, LLC. Device class: 2.

Clearance details

Applicant: Isolux, LLC
Product code: Code HBI
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2005-10-24
Decision date: 2005-10-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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