Cleared Traditional

VS3 Iridium Sytem (K210265) - FDA 510(k) Clearance

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

K210265 · Visionsense, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2021
Decision
294d
Days
Class 2
Risk

K210265 is an FDA 510(k) clearance for the VS3 Iridium Sytem. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Visionsense, Ltd. (Petach Tikva, Hamerkaz, IL). The FDA issued a Cleared decision on November 22, 2021 after a review of 294 days - an extended review cycle.

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 Visionsense, Ltd. devices

Submission Details

510(k) Number K210265 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 01, 2021
Decision Date November 22, 2021
Days to Decision 294 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
179d slower than avg
Panel avg: 115d · This submission: 294d
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 K210265.
VS3-Iridium System (VS3-IR)
K223020 · Visionsense, Ltd. · Oct 2022
780 nm L11 LED Light Source with AIM
K221611 · Stryker · Jun 2022
Cellvizio 100 series system with confocal Miniprobes
K220477 · Mauna Kea Technologies · Apr 2022
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
ActivSight Intraoperative Imaging System
K203550 · Activ Surgical, Inc. · Apr 2021