Cleared Traditional

K112133 - OASYS SURGICAL LIGHT CONTROLLER

K112133 is an FDA 510(k) clearance for OASYS SURGICAL LIGHT CONTROLLER, manufactured by Oasys Healthcare. The device is a Class 2 General & Plastic Surgery device with product code FTA cleared through the Traditional 510(k) pathway after a 219-day FDA review.

K112133 · Oasys Healthcare · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Mar 2012
Decision
219d
Days
Class 2
Risk

K112133 is an FDA 510(k) clearance for the OASYS SURGICAL LIGHT CONTROLLER. Classified as Light, Surgical, Accessories (product code FTA), Class II - Special Controls.

Submitted by Oasys Healthcare (Appollo Beach, US). The FDA issued a Cleared decision on March 1, 2012 after a review of 219 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

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FDA 510(k) Submission Details - K112133

510(k) Number K112133 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
104d slower than avg
Panel avg: 115d · This submission: 219d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FTA Device Classification - Class 2, Special Controls

Product Code FTA Light, Surgical, Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - FTA Light, Surgical, Accessories

All 16
Devices cleared under the same product code (FTA) and FDA review panel - the closest regulatory comparables to K112133.
Operating Room Light Handle Adapter
K142386 · Litex Manufacturing, Inc. · Sep 2014
SURGICAL LIGHT HANDLE COVER
K133554 · Microtek Medical, Inc. an Ecolab Company · Apr 2014
IDSS SLC
K133413 · Black Diamond Video · Jan 2014
EASYSUITE SURGICAL LIGHT CONTROL (ESLC)
K102791 · Image Stream Medical, Inc. · Nov 2010
MAINSTREAM OR SURGICAL LIGHT CONTROL (MSLC)
K081698 · Image Stream Medical, Inc. · Jul 2008
LIGHT GUARD LIGHT HANDLE AND LIGHT HANDLE COVER
K053321 · Xodus Medical, Inc. · Jan 2006