Cleared Special

K162013 - Eusol-C (FDA 510(k) Clearance)

K162013 · Al.Chi.Mi.A. S.R.L · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2016
Decision
56d
Days
-
Risk

K162013 is an FDA 510(k) clearance for the Eusol-C. Classified as Media, Corneal Storage (product code LYX).

Submitted by Al.Chi.Mi.A. S.R.L (Ponte San Nicolo, IT). The FDA issued a Cleared decision on September 15, 2016 after a review of 56 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.

View all Al.Chi.Mi.A. S.R.L devices

Submission Details

510(k) Number K162013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 21, 2016
Decision Date September 15, 2016
Days to Decision 56 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 110d · This submission: 56d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code LYX Media, Corneal Storage
Device Class -