Cleared Traditional

Cellvizio 100 Series System with Confocal Miniprobes (K172844) - FDA 510(k) Clearance

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

K172844 · Mauna Kea Technologies · General & Plastic Surgery device
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Dec 2017
Decision
87d
Days
Class 2
Risk

K172844 is an FDA 510(k) clearance for the Cellvizio 100 Series System with Confocal Miniprobes. Classified as Confocal Optical Imaging (product code OWN), Class II - Special Controls.

Submitted by Mauna Kea Technologies (Paris, FR). The FDA issued a Cleared decision on December 15, 2017 after a review of 87 days - a notably fast clearance 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: 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 Mauna Kea Technologies devices

Submission Details

510(k) Number K172844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 19, 2017
Decision Date December 15, 2017
Days to Decision 87 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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 K172844.
VS3-IR
K183453 · Medtronic · Mar 2019
Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes
K183640 · Mauna Kea Technologies · Feb 2019
Stryker AIM Light Source and SafeLight cable
K173866 · Stryker · Jan 2018
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