The following data is part of a premarket notification filed by Optimedica Corporation with the FDA for Catalys Precision Laser System.
| Device ID | K161455 |
| 510k Number | K161455 |
| Device Name: | Catalys Precision Laser System |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | Optimedica Corporation 1310 Moffet Park Drive Sunnyvale, CA 94089 |
| Contact | Ankur Kaushal |
| Correspondent | Ankur Kaushal Optimedica Corporation 1310 Moffet 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 | 2016-05-26 |
| Decision Date | 2016-09-20 |
| Summary: | summary |