Cleared Special

K062763 - NONCON ROBO PACHY F&A (FDA 510(k) Clearance)

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

K062763 · Konan Medical, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2008
Decision
525d
Days
Class 2
Risk

K062763 is an FDA 510(k) clearance for the NONCON ROBO PACHY F&A. Classified as Microscope, Specular (product code NQE), Class II - Special Controls.

Submitted by Konan Medical, Inc. (Hasbrouck Heights, US). The FDA issued a Cleared decision on February 22, 2008 after a review of 525 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Konan Medical, Inc. devices

Submission Details

510(k) Number K062763 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2006
Decision Date February 22, 2008
Days to Decision 525 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
415d slower than avg
Panel avg: 110d · This submission: 525d
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.