The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Argon/krypton Laser System 8500.
| Device ID | K844209 |
| 510k Number | K844209 |
| Device Name: | ARGON/KRYPTON LASER SYSTEM 8500 |
| Classification | Photocoagulator And Accessories |
| 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 | HQB |
| CFR Regulation Number | 886.4690 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-10-31 |
| Decision Date | 1985-02-06 |