The following data is part of a premarket notification filed by Coopervision, Inc. with the FDA for Model 1000 Ophthalmic Laser System.
| Device ID | K862987 |
| 510k Number | K862987 |
| Device Name: | MODEL 1000 OPHTHALMIC LASER SYSTEM |
| Classification | Laser, Ophthalmic |
| Applicant | COOPERVISION, INC. LASER DIVISION 3420 CENTRAL EXPRESSWAY Santa Clara, CA 95051 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose COOPERVISION, INC. LASER DIVISION 3420 CENTRAL EXPRESSWAY Santa Clara, CA 95051 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-07 |
| Decision Date | 1986-09-24 |