Cleared Traditional

OASYS SURGICAL LIGHT CONTROLLER

K112133 · Oasys Healthcare · General & Plastic Surgery
Mar 2012
Decision
219d
Days
Class 2
Risk

About This 510(k) Submission

K112133 is an FDA 510(k) clearance for the OASYS SURGICAL LIGHT CONTROLLER, a Light, Surgical, Accessories (Class II — Special Controls, product code FTA), submitted by Oasys Healthcare (Apollo Beach, US). The FDA issued a Cleared decision on March 1, 2012, 219 days after receiving the submission on July 26, 2011. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4580.

Submission Details

510(k) Number K112133 FDA.gov
FDA Decision Cleared SESE
Date Received July 26, 2011
Decision Date March 01, 2012
Days to Decision 219 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FTA — Light, Surgical, Accessories
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.4580

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