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 | K210701 |
| 510k Number | K210701 |
| Device Name: | CATALYS Precision Laser System |
| Classification | Ophthalmic Femtosecond Laser |
| Applicant | AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
| Contact | Laarni Ricafort |
| Correspondent | Laarni Ricafort AMO Manufacturing USA, LLC 510 Cottonwood Drive Milpitas, CA 95035 |
| Product Code | OOE |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-03-09 |
| Decision Date | 2021-04-07 |