The following data is part of a premarket notification filed by Staar Surgical Co. with the FDA for Epiphany Injection System.
| Device ID | K090161 |
| 510k Number | K090161 |
| Device Name: | EPIPHANY INJECTION SYSTEM |
| Classification | Folders And Injectors, Intraocular Lens (iol) |
| Applicant | STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Contact | Diana Smith |
| Correspondent | Diana Smith STAAR SURGICAL CO. 1911 WALKER AVE. Monrovia, CA 91016 |
| Product Code | MSS |
| CFR Regulation Number | 886.4300 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-01-22 |
| Decision Date | 2009-06-09 |
| Summary: | summary |