OASYS SURGICAL LIGHT CONTROLLER— 510(k) K112133

Name: FDA 510(k) clearance K112133
Creator: U.S. Food and Drug Administration
Published: 2012-03-01

Substantially Equivalent

Oasys Healthcare

FDA 510(k) clearance K112133 for OASYS SURGICAL LIGHT CONTROLLER, Substantially Equivalent on 2012-03-01. Applicant: Oasys Healthcare. Device class: 2.

Clearance details

Applicant: Oasys Healthcare
Product code: Code FTA
Device class: Class 2
Regulation: 21 CFR 878.4580
Advisory panel: General, Plastic Surgery
Date received: 2011-07-26
Decision date: 2012-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Appollo Beach, 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.