Cleared Traditional

ActivSight Intraoperative Imaging System (K203550) - FDA 510(k) Clearance

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

K203550 · Activ Surgical, Inc. · General & Plastic Surgery device
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Apr 2021
Decision
125d
Days
Class 2
Risk

K203550 is an FDA 510(k) clearance for the ActivSight Intraoperative Imaging System. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Activ Surgical, Inc. (Boston, US). The FDA issued a Cleared decision on April 8, 2021 after a review of 125 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 876.1500 - 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 Activ Surgical, Inc. devices

Submission Details

510(k) Number K203550 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2020
Decision Date April 08, 2021
Days to Decision 125 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
10d slower than avg
Panel avg: 115d · This submission: 125d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code OWN Confocal Optical Imaging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.1500
Definition Collection Of Light Signals For Visualization Of Cellular Microstructures.
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 - OWN Confocal Optical Imaging

All 41
Devices cleared under the same product code (OWN) and FDA review panel - the closest regulatory comparables to K203550.
VS3 Iridium Sytem
K210265 · Visionsense, Ltd. · Nov 2021
KARL STORZ ICG Imaging System
K212695 · Karl Storz Endoscopy America · Nov 2021
Cellvizio I.V.E. system with Confocal Miniprobes
K212322 · Mauna Kea Technologies · Aug 2021
KARL STORZ ICG Imaging System
K202925 · KARL STORZ Endoscopy-America, Inc. · Dec 2020
SPY-PHI System with SPY-PHI Fluorescence Assessment Software
K202244 · Novadaq Technologies Ulc. (Now A Part of Stryker) · Nov 2020
HOPKINS ICG/NIR 10mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 5mm Ridgid Endoscope (modified) 0°, 30°, 45°, HOPKIN ICG/NIR 4mm Ridgid Endoscope 0°, 30°, 45°, VITOM II ICG/NIR Telescope, Power LED Rubina Light Source, Foot Switch, Fiber Optic Light Cable, Image S CCU, Image S 4U Rubina Camera Head
K201399 · KARL STORZ Endoscopy-America, Inc. · Aug 2020