Cleared Traditional

Cellvizio 100 Series System with Confocal Miniprobes (K191144) - FDA 510(k) Clearance

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

K191144 · Mauna Kea Technologies · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2020
Decision
269d
Days
Class 2
Risk

K191144 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 January 24, 2020 after a review of 269 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 Mauna Kea Technologies devices

Submission Details

510(k) Number K191144 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2019
Decision Date January 24, 2020
Days to Decision 269 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
154d slower than avg
Panel avg: 115d · This submission: 269d
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 Consultant

Daniel & Daniel Consulting
Michael A. Daniel

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K191144.
Visera Elite II Xenon Light Source, Telescope IR/Telescope Ultra, Visera Elite II Video System Center, HD 3CMOS Autoclavable Camera Head, HD 3CMOS Camera Head
K200542 · Olympus Medical Systems Corp. · Jul 2020
SPY Portable Handheld Imaging (SPY-PHI) System
K200737 · Novadaq Technologies Ulc. (Now A Part of Stryker) · May 2020
Cellvizio I.V.E. with Confocal Miniprobes
K193416 · Mauna Kea Technologies · Feb 2020
VS3-IR
K191851 · Medtronic · Nov 2019
L10 LED Light Source with AIM, L11 LED Light Source with AIM, AIM SafeLight Cable
K192292 · Stryker · Nov 2019
SPY Portable Handheld Imaging (SPY-PHI) System
K192174 · Novadaq Technologies Ulc. (Now A Part of Stryker) · Nov 2019