Cleared Traditional

VIVASCOPE SYSTEM, MODEL 1500, 3000 (K080788) - FDA 510(k) Clearance

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

K080788 · Lucid, Inc. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Sep 2008
Decision
181d
Days
Class 2
Risk

K080788 is an FDA 510(k) clearance for the VIVASCOPE SYSTEM, MODEL 1500, 3000. Classified as Light Based Imaging (product code PSN), Class II - Special Controls.

Submitted by Lucid, Inc. (Rochester, US). The FDA issued a Cleared decision on September 17, 2008 after a review of 181 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4580 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Lucid, Inc. devices

Submission Details

510(k) Number K080788 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2008
Decision Date September 17, 2008
Days to Decision 181 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
66d slower than avg
Panel avg: 115d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PSN Light Based Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4580
Definition Emission And Collection Of Light To Create An Image For Medical Purposes
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 - PSN Light Based Imaging

All 9
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