Cleared Special

K143678 - NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Accessory

K143678 is an FDA 510(k) clearance for NvisionVLE Imaging System, manufactured by Ninepoint Medical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code NQQ cleared through the Special 510(k) pathway after a 44-day FDA review.

K143678 · Ninepoint Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
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Feb 2015
Decision
44d
Days
Class 2
Risk

K143678 is an FDA 510(k) clearance for the NvisionVLE Imaging System, NvisionVLE Optical Probe, NvisionVLE Inflation Acc.... Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Ninepoint Medical, Inc. (Cambridge, US). The FDA issued a Cleared decision on February 6, 2015 after a review of 44 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Ninepoint Medical, Inc. devices

FDA 510(k) Submission Details - K143678

510(k) Number K143678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 24, 2014
Decision Date February 06, 2015
Days to Decision 44 days
Submission Type Special
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
71d faster than avg
Panel avg: 115d · This submission: 44d
Pathway characteristics
Modification to existing cleared device.

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 K143678.
OPTIS Integrated System Mobile Workstation
K151286 · Lightlab Imaging, Inc. · Aug 2015
ILUMIEN OPTIS
K150878 · Lightlab Imaging, Inc. · Jul 2015
ILUMIEN, Drageonfly OPTIS Imaging Catheter
K150237 · Lightlab Imaging, Inc. · May 2015
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