EQUINOX CO2 LASER— 510(k) K131903

Substantially Equivalent

Eclipse Aesthetics, LLC

FDA 510(k) clearance K131903 for EQUINOX CO2 LASER, Substantially Equivalent on 2013-09-19. Applicant: Eclipse Aesthetics, LLC. Device class: 2.

Clearance details

Applicant: Eclipse Aesthetics, LLC
Product code: Code ONG
Device class: Class 2
Regulation: 21 CFR 878.4810
Advisory panel: General, Plastic Surgery
Date received: 2013-06-25
Decision date: 2013-09-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Dallas, TX, 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.