The following data is part of a premarket notification filed by Optimedica Corporation with the FDA for Catalys Precision Laser System.
| Device ID | K121091 |
| 510k Number | K121091 |
| Device Name: | CATALYS PRECISION LASER SYSTEM |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | OPTIMEDICA CORPORATION 1310 MOFFETT PARK DRIVE Sunnyvale, CA 94089 |
| Contact | Alan Marquardt |
| Correspondent | Alan Marquardt OPTIMEDICA CORPORATION 1310 MOFFETT PARK DRIVE Sunnyvale, CA 94089 |
| Product Code | OOE |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-04-10 |
| Decision Date | 2012-08-28 |
| Summary: | summary |