Cleared Traditional

K123369 - ILUMIEN OPTIS

K123369 is an FDA 510(k) clearance for ILUMIEN OPTIS, manufactured by Lightlab Imaging, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NQQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K123369 · Lightlab Imaging, Inc. · General & Plastic Surgery device
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Jan 2013
Decision
90d
Days
Class 2
Risk

K123369 is an FDA 510(k) clearance for the ILUMIEN OPTIS. Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Lightlab Imaging, Inc. (Westford, US). The FDA issued a Cleared decision on January 30, 2013 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 892.1560 - 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.

View all Lightlab Imaging, Inc. devices

FDA 510(k) Submission Details - K123369

510(k) Number K123369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2012
Decision Date January 30, 2013
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NQQ Device Classification - Class 2, Special Controls

Product Code NQQ System, Imaging, Optical Coherence Tomography (oct)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
Definition This Device Uses Back-reflected Light To Create Two-dimensional Images Versus Back-reflected Sound Waves As Are Used In Ultrasound Imaging.
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.