Cleared Traditional

K093520 - VIVOSIGHT TOPICAL OCT SYSTEM

K093520 is an FDA 510(k) clearance for VIVOSIGHT TOPICAL OCT SYSTEM, manufactured by Michelson Diagnostics, Ltd.. The device is a Class 2 General & Plastic Surgery device with product code NQQ cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K093520 · Michelson Diagnostics, Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Jan 2010
Decision
53d
Days
Class 2
Risk

K093520 is an FDA 510(k) clearance for the VIVOSIGHT TOPICAL OCT SYSTEM. Classified as System, Imaging, Optical Coherence Tomography (oct) (product code NQQ), Class II - Special Controls.

Submitted by Michelson Diagnostics, Ltd. (Orpington, Kent, GB). The FDA issued a Cleared decision on January 5, 2010 after a review of 53 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 Michelson Diagnostics, Ltd. devices

FDA 510(k) Submission Details - K093520

510(k) Number K093520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 13, 2009
Decision Date January 05, 2010
Days to Decision 53 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
62d faster than avg
Panel avg: 115d · This submission: 53d
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.