ISOLUX SURGICAL HEADLIGHT— 510(k) K991572

Substantially Equivalent

Isolux America

FDA 510(k) clearance K991572 for ISOLUX SURGICAL HEADLIGHT, Substantially Equivalent on 1999-07-08. Applicant: Isolux America. Device class: 2.

Clearance details

Applicant: Isolux America
Product code: Code FST
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 1999-05-05
Decision date: 1999-07-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Naples, FL, US

Download summary PDF View on FDA.gov ↗

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More clearances from Isolux America

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