Cleared Special

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

K162013 · Al.Chi.Mi.A. S.R.L · Ophthalmic device
Sep 2016
Decision
56d
Days
-
Risk

K162013 is an FDA 510(k) clearance for the Eusol-C. This device is classified as a Media, Corneal Storage.

Submitted by Al.Chi.Mi.A. S.R.L (Ponte San Nicolo, IT). The FDA issued a Cleared decision on September 15, 2016, 56 days after receiving the submission on July 21, 2016.

This device falls under the Ophthalmic FDA review panel.

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

Device Classification

Product Code LYX - Media, Corneal Storage
Device Class -