The following data is part of a premarket notification filed by Amo Manufacturing Usa, Llc with the FDA for Catalys Precision Laser System.
| Device ID | K172002 |
| 510k Number | K172002 |
| Device Name: | Catalys Precision Laser System |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
| Contact | Anita Xavier |
| Correspondent | Anita Xavier AMO Manufacturing USA, LLC 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 | 2017-07-03 |
| Decision Date | 2017-08-25 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05050474617186 | K172002 | 000 |
| 05050474611764 | K172002 | 000 |