DEN200063 is an FDA 510(k) submission for the Kerasave. This device is classified as a Corneal Storage Media With Preservatives Including Anti-fungal (Class II - Special Controls, product code QCW).
Submitted by Al.Chi.Mi.A. S.R.L (Ponte San Nicolò, IT). The FDA issued a Not Cleared (DENG) decision on May 2, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4320. Media To Preserve Human Corneas While In Storage..
| 510(k) Number | DEN200063 FDA.gov |
| FDA Decision | Not Cleared Not Substantially Equivalent (DENG) |
| Date Received | October 01, 2020 |
| Decision Date | May 02, 2022 |
| Days to Decision | 578 days |
| Submission Type | Post-NSE |
| Review Panel | Ophthalmic (OP) |
| Summary | - |
| Product Code | QCW - Corneal Storage Media With Preservatives Including Anti-fungal |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4320 |
| Definition | Media To Preserve Human Corneas While In Storage. |