Cleared Traditional

NVISION VLE IMAGING SYSTEM (K120800) - FDA 510(k) Clearance

Class II General & Plastic Surgery device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K120800 · Ninepoint Medical, Inc. · General & Plastic Surgery device
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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

Submission Details

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
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.

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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