Cleared Traditional

K093857 - C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES

K093857 is an FDA 510(k) clearance for C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY ..., 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 135-day FDA review.

K093857 · 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
Apr 2010
Decision
135d
Days
Class 2
Risk

K093857 is an FDA 510(k) clearance for the C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESS.... Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Lightlab Imaging, Inc. (Rockville, US). The FDA issued a Cleared decision on April 30, 2010 after a review of 135 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 - K093857

510(k) Number K093857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 16, 2009
Decision Date April 30, 2010
Days to Decision 135 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
20d slower than avg
Panel avg: 115d · This submission: 135d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. 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 K093857.
NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER
K112770 · Ninepoint Medical, Inc. · Dec 2011
C7 XR IMAGING SYSTEM
K111201 · Lightlab Imaging, Inc. · Aug 2011
TOMOPHASE OCTIS
K102599 · Tomophase Corporation · Dec 2010
VIVOSIGHT TOPICAL OCT SYSTEM
K093520 · Michelson Diagnostics, Ltd. · Jan 2010
IMALUX NIRIS IMAGING SYSTEM
K042894 · Imalux Corporation · Nov 2004
IMALUX OCT IMAGING SYSTEM
K033783 · Imalux Coporation · Mar 2004
K093857 · C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES
Download PDF FDA Summary Lightlab Imaging, Inc.