QCW · Corneal Storage Media With Preservatives Including Anti-Fungal
Ophthalmic · 21 CFR 886.4320 · Class 2
Overview
| Product Code | QCW |
|---|---|
| Device Name | Corneal Storage Media With Preservatives Including Anti-Fungal |
| Regulation | 21 CFR 886.4320 |
| Device Class | Class 2 |
| Review Panel | Ophthalmic |
Identification
Kerasave is a buffered corneal storage medium with preservatives, including antibiotics (gentamicin sulfate and streptomycin sulfate) and an antifungal agent (Amphotericin B), used to temporarily preserve human cornea tissue at 2-8°C for up to 14 days between harvesting and implantation. It is intended for prescription use by physicians or highly skilled personnel, such as Eye Bank operators.
Classification Rationale
Class II (special controls). The device is classified as Class II because it is a corneal storage medium with preservatives including antifungals, and the identified risks to health can be mitigated by general controls and the established special controls.
Special Controls
In combination with the general controls of the FD&C Act, the corneal storage medium with preservatives including antifungals is subject to the following special controls:
Cleared Devices (1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| DEN200063 | Kerasave | Al.Chi.Mi.A. S.R.L | May 2, 2022 | DENG |
Top Applicants
- Al.Chi.Mi.A. S.R.L — 1 clearance
