Cleared Special

K120264 - KONAN SPECULAR MICROSCOPE XIV (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K120264 · Konan Medical, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Apr 2012
Decision
72d
Days
Class 2
Risk

K120264 is an FDA 510(k) clearance for the KONAN SPECULAR MICROSCOPE XIV. Classified as Microscope, Specular (product code NQE), Class II - Special Controls.

Submitted by Konan Medical, Inc. (San Clemente, US). The FDA issued a Cleared decision on April 11, 2012 after a review of 72 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.1850 - the FDA ophthalmic 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. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Konan Medical, Inc. devices

Submission Details

510(k) Number K120264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 30, 2012
Decision Date April 11, 2012
Days to Decision 72 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
38d faster than avg
Panel avg: 110d · This submission: 72d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code NQE Microscope, Specular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.1850
Definition Specular Microscopes Are Used For The Microscopic Imaging And Assessment Of The Corneal Endothelial Cell Layer In Vivo Or In Vitro.
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 Ophthalmic devices follow this clearance model.