Cleared Traditional

K112770 - NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER

K112770 is an FDA 510(k) clearance for NVISION VLE IMAGING SYSTEM, manufactured by Ninepoint Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NQQ cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K112770 · Ninepoint Medical, Inc. · General & Plastic Surgery device
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Dec 2011
Decision
84d
Days
Class 2
Risk

K112770 is an FDA 510(k) clearance for the NVISION VLE IMAGING SYSTEM, NVISION VLE CATHETER. Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Ninepoint Medical, Inc. (Hillsborough, US). The FDA issued a Cleared decision on December 16, 2011 after a review of 84 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 Ninepoint Medical, Inc. devices

FDA 510(k) Submission Details - K112770

510(k) Number K112770 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2011
Decision Date December 16, 2011
Days to Decision 84 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
31d faster than avg
Panel avg: 115d · This submission: 84d
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 41
Devices cleared under the same product code (NQQ) and FDA review panel - the closest regulatory comparables to K112770.
NVISION VLE IMAGING SYSTEM
K120800 · Ninepoint Medical, Inc. · Apr 2013
ILUMIEN OPTIS
K123369 · Lightlab Imaging, Inc. · Jan 2013
NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
K121195 · Ninepoint Medical, Inc. · Jul 2012
C7 XR IMAGING SYSTEM
K111201 · Lightlab Imaging, Inc. · Aug 2011
IMALUX NIRIS IMAGING SYSTEM
K042894 · Imalux Corporation · Nov 2004