Cleared Special

K121195 - NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER

K121195 is an FDA 510(k) clearance for NVISION VLE IMAGING SYSTEM NVISION VLE ..., 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 97-day FDA review.

K121195 · Ninepoint Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
97d
Days
Class 2
Risk

K121195 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 July 25, 2012 after a review of 97 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K121195

510(k) Number K121195 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 19, 2012
Decision Date July 25, 2012
Days to Decision 97 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
18d faster than avg
Panel avg: 115d · This submission: 97d
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 45
Devices cleared under the same product code (NQQ) and FDA review panel - the closest regulatory comparables to K121195.
SKINTELL
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NVISION VLE IMAGING SYSTEM
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K123369 · Lightlab Imaging, Inc. · Jan 2013
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K112770 · Ninepoint Medical, Inc. · Dec 2011
C7 XR IMAGING SYSTEM
K111201 · Lightlab Imaging, Inc. · Aug 2011
TOMOPHASE OCTIS
K102599 · Tomophase Corporation · Dec 2010
K121195 · NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER
Download PDF FDA Summary Ninepoint Medical, In…