510(k) DEN230011

OcuCool by Recensmedical, Inc. — Product Code QZQ

DEN230011 is an FDA 510(k) premarket notification submitted by Recensmedical, Inc. for the device "OcuCool". The FDA issued a decision of De Novo Granted on September 30, 2024. Recensmedical, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
DENG (De Novo Granted)
Decision Date
September 30, 2024
Date Received
February 16, 2023
Clearance Type
Direct
Expedited Review
No
Third Party Review
No