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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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.

Regulatory Peers - NQQ System, Imaging, Optical Coherence Tomography (oct)

All 45
Devices cleared under the same product code (NQQ) and FDA review panel - the closest regulatory comparables to K123369.
FORESEE (4C) IMAGING SYSTEM
K133209 · Diagnostic Photonics, Inc. · Mar 2014
SKINTELL
K132800 · Agfa Healthcare N.V. · Mar 2014
NVISION VLE IMAGING SYSTEM
K120800 · Ninepoint Medical, Inc. · Apr 2013
NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
K121195 · Ninepoint Medical, Inc. · Jul 2012
NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
K112770 · Ninepoint Medical, Inc. · Dec 2011
C7 XR IMAGING SYSTEM
K111201 · Lightlab Imaging, Inc. · Aug 2011
K123369 · ILUMIEN OPTIS
Download PDF FDA Summary Lightlab Imaging, Inc.