Not Cleared Direct

DEN230011 - OcuCool (FDA 510(k) Clearance)

DEN230011 · Recensmedical, Inc. · Ophthalmic device
Sep 2024
Decision
592d
Days
-
Risk

DEN230011 is an FDA 510(k) submission for the OcuCool..

Submitted by Recensmedical, Inc. (Hwaseong-Si, KR). The FDA issued a Not Cleared (DENG) decision on September 30, 2024.

This device falls under the Ophthalmic FDA review panel.

Submission Details

510(k) Number DEN230011 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 16, 2023
Decision Date September 30, 2024
Days to Decision 592 days
Submission Type Direct
Review Panel Ophthalmic (OP)
Summary -

Device Classification

Product Code QZQ
Device Class -