The following data is part of a premarket notification filed by Abbott Medical Optics Inc. with the FDA for Catalys Precision Laser System.
| Device ID | K170322 |
| 510k Number | K170322 |
| Device Name: | Catalys Precision Laser System |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | Abbott Medical Optics Inc. 510 Cottonwood Drive Milpitas, CA 95035 |
| Contact | Audrey Munnerlyn |
| Correspondent | Audrey Munnerlyn Abbott Medical Optics Inc. 510 Cottonwood Drive Milpitas, CA 95035 |
| Product Code | OOE |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-02-01 |
| Decision Date | 2017-05-19 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05050474651487 | K170322 | 000 |
| 05050474609778 | K170322 | 000 |
| 05050474609761 | K170322 | 000 |