OptiLux LED Illuminator— 510(k) K163185

Substantially Equivalent

Isolux, LLC

FDA 510(k) clearance K163185 for OptiLux LED Illuminator, Substantially Equivalent on 2016-11-21. 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: 2016-11-14
Decision date: 2016-11-21
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.