Cleared Special

NVISION VLE IMAGING SYSTEM NVISION VLE CATHETER (K121195) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K121195 · Ninepoint Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Ninepoint Medical, Inc. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
18d faster than avg
Panel avg: 115d · This submission: 97d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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
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