Cleared Traditional

K120800 - NVISION VLE IMAGING SYSTEM

K120800 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 405-day FDA review.

K120800 · Ninepoint Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2013
Decision
405d
Days
Class 2
Risk

K120800 is an FDA 510(k) clearance for the NVISION VLE IMAGING SYSTEM. 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 April 25, 2013 after a review of 405 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Ninepoint Medical, Inc. devices

FDA 510(k) Submission Details - K120800

510(k) Number K120800 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received March 16, 2012
Decision Date April 25, 2013
Days to Decision 405 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
290d slower than avg
Panel avg: 115d · This submission: 405d
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 K120800.
NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory
K143678 · Ninepoint Medical, Inc. · Feb 2015
FORESEE (4C) IMAGING SYSTEM
K133209 · Diagnostic Photonics, Inc. · Mar 2014
SKINTELL
K132800 · Agfa Healthcare N.V. · Mar 2014
ILUMIEN OPTIS
K123369 · Lightlab Imaging, Inc. · Jan 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