The following data is part of a premarket notification filed by Glaukos with the FDA for Iprime Viscodelivery System.
| Device ID | K212797 |
| 510k Number | K212797 |
| Device Name: | IPrime Viscodelivery System |
| Classification | Pump, Infusion, Ophthalmic |
| Applicant | Glaukos 229 Avenida Fabricante San Clemente, CA 92672 |
| Contact | Alex Bhaskarla |
| Correspondent | Alex Bhaskarla Glaukos 229 Avenida Fabricante San Clemente, CA 92672 |
| Product Code | MRH |
| CFR Regulation Number | 880.5725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-09-02 |
| Decision Date | 2022-01-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853704002456 | K212797 | 000 |