The following data is part of a premarket notification filed by Optimedica Corporation with the FDA for Optimedica Catalys Precision Laser System.
| Device ID | K141079 |
| 510k Number | K141079 |
| Device Name: | OPTIMEDICA CATALYS PRECISION LASER SYSTEM |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | OPTIMEDICA CORPORATION 1310 MOFFETT PARK DRIVE Sunnyvale, CA 94089 |
| Contact | Steve Jwanouskos |
| Correspondent | Steve Jwanouskos 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 | 2014-04-25 |
| Decision Date | 2014-09-11 |
| Summary: | summary |