Cleared Special

K063617 - EUSOL-C

K063617 · Al.Chi.Mi.A · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2007
Decision
65d
Days
-
Risk

K063617 is an FDA 510(k) clearance for the EUSOL-C. Classified as Media, Corneal Storage (product code LYX).

Submitted by Al.Chi.Mi.A (Hasbrouck Heights, US). The FDA issued a Cleared decision on February 8, 2007 after a review of 65 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel. 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.

FDA 510(k) Submission Details - K063617

510(k) Number K063617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 05, 2006
Decision Date February 08, 2007
Days to Decision 65 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
45d faster than avg
Panel avg: 110d · This submission: 65d
Pathway characteristics
Modification to existing cleared device.

LYX Device Classification - Class 0,

Product Code LYX Media, Corneal Storage
Device Class -
K063617 · EUSOL-C
Download PDF FDA Summary Al.Chi.Mi.A