Cleared Special

K111047 - CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES

K111047 is an FDA 510(k) clearance for CELLVIZIO 100 SERIES SYSTEM WITH CONFOC..., manufactured by Mauna Kea Technologies, Inc.. The device is a Class 2 General & Plastic Surgery device with product code OWN cleared through the Special 510(k) pathway after a 115-day FDA review.

K111047 · Mauna Kea Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2011
Decision
115d
Days
Class 2
Risk

K111047 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, Inc. (Newton, US). The FDA issued a Cleared decision on August 8, 2011 after a review of 115 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K111047

510(k) Number K111047 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 15, 2011
Decision Date August 08, 2011
Days to Decision 115 days
Submission Type Special
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
At panel average
Panel avg: 115d · This submission: 115d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

OWN Device Classification - Class 2, Special Controls

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

Tuv Rheinland of North America, Inc.
MICHAEL S OGUNLEYE

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.

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K111047 · CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
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