The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Model 8000 Nd:yag Laser Sys Treatment Of Benign Le.
| Device ID | K844668 |
| 510k Number | K844668 |
| Device Name: | MODEL 8000 ND:YAG LASER SYS TREATMENT OF BENIGN LE |
| Classification | Laser, Ophthalmic |
| Applicant | COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Contact | Charles L Rose |
| Correspondent | Charles L Rose COOPER LASERSONICS, INC. 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 | 1984-11-30 |
| Decision Date | 1985-01-03 |