Cleared Traditional

IMALUX OCT IMAGING SYSTEM (K033783) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K033783 · Imalux Coporation · General & Plastic Surgery device
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Mar 2004
Decision
88d
Days
Class 2
Risk

K033783 is an FDA 510(k) clearance for the IMALUX OCT IMAGING SYSTEM. Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Imalux Coporation (Cleveland, US). The FDA issued a Cleared decision on March 1, 2004 after a review of 88 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Imalux Coporation devices

Submission Details

510(k) Number K033783 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2003
Decision Date March 01, 2004
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 23
Devices cleared under the same product code (NQQ) and FDA review panel - the closest regulatory comparables to K033783.
OTIS Optical Coherence Tomography SYstem
K190404 · Perimeter Medical Imaging, Inc. · Mar 2019
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation System
K182616 · Ninepoint Medical, Inc. · Nov 2018
NvisionVLE Imaging System, NvisionVLE Optical Probe
K182261 · Ninepoint Medical, Inc. · Oct 2018