The following data is part of a premarket notification filed by Advanced Medical Optics, Inc. with the FDA for The Amo Ophthalmic Surgical System.
| Device ID | K060366 |
| 510k Number | K060366 |
| Device Name: | THE AMO OPHTHALMIC SURGICAL SYSTEM |
| Classification | Unit, Phacofragmentation |
| Applicant | ADVANCED MEDICAL OPTICS, INC. 1700 EAST ST. ANDREW PL. MAIL STOP: SA-2J Santa Ana, CA 92799 |
| Contact | Toni Elliott |
| Correspondent | Toni Elliott ADVANCED MEDICAL OPTICS, INC. 1700 EAST ST. ANDREW PL. MAIL STOP: SA-2J Santa Ana, CA 92799 |
| Product Code | HQC |
| CFR Regulation Number | 886.4670 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-13 |
| Decision Date | 2006-04-07 |
| Summary: | summary |