ISOLED AC-POWERED LED HEADLIGHT SYSTEM— 510(k) K102266

Name: FDA 510(k) clearance K102266
Creator: U.S. Food and Drug Administration
Published: 2010-09-24

Substantially Equivalent

Isolux, LLC

FDA 510(k) clearance K102266 for ISOLED AC-POWERED LED HEADLIGHT SYSTEM, Substantially Equivalent on 2010-09-24. Applicant: Isolux, LLC. Device class: 2.

Clearance details

Applicant: Isolux, LLC
Product code: Code FST
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2010-08-10
Decision date: 2010-09-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.