Cleared Traditional

CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES (K141358) - FDA 510(k) Clearance

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

K141358 · Mauna Kea Technologies · General & Plastic Surgery device
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Sep 2014
Decision
125d
Days
Class 2
Risk

K141358 is an FDA 510(k) clearance for the CELLVIZIO 100 SERIES WITH SYSTEM CONFOCAL MINIPROBES. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Mauna Kea Technologies (Gardnerville, US). The FDA issued a Cleared decision on September 25, 2014 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 Mauna Kea Technologies devices

Submission Details

510(k) Number K141358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 23, 2014
Decision Date September 25, 2014
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
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 42
Devices cleared under the same product code (OWN) and FDA review panel - the closest regulatory comparables to K141358.
KARL STORZ ICG Imaging System
K171238 · KARL STORZ Endoscopy-America, Inc. · May 2017
KARL STORZ ICG Imaging System
K162882 · KARL STORZ Endoscopy-America, Inc. · Jan 2017
KARL STORZ Endoscopic ICG Imaging System
K152583 · KARL STORZ Endoscopy-America, Inc. · May 2016
DA VINCI FLUORESCENCE IMAGING VISION SYSTEM
K124031 · Intuitive Surgical, Inc. · Sep 2013