Cleared Traditional

K153479 - NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVLE Marking Probe, 17mm balloon,NvisionVLE Marking Probe, 14mm balloon, NvisionVLE Inflation System

K153479 is an FDA 510(k) clearance for NvisionVLE Imaging Console, 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 76-day FDA review.

K153479 · Ninepoint Medical, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2016
Decision
76d
Days
Class 2
Risk

K153479 is an FDA 510(k) clearance for the NvisionVLE Imaging Console, NvisionVLE Marking Probe, 20mm balloon, NvisionVL.... Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Ninepoint Medical, Inc. (Bedford, US). The FDA issued a Cleared decision on February 16, 2016 after a review of 76 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 - K153479

510(k) Number K153479 FDA.gov
FDA Decision Cleared Substantially Equivalent - Abbreviated 510(k) (SESU)
Date Received December 02, 2015
Decision Date February 16, 2016
Days to Decision 76 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
39d faster than avg
Panel avg: 115d · This submission: 76d
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 K153479.
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