The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Molectron Medical Nd:yag Laser, Model 8000.
| Device ID | K833480 |
| 510k Number | K833480 |
| Device Name: | MOLECTRON MEDICAL ND:YAG LASER, MODEL 8000 |
| Classification | Laser For Gastro-urology Use |
| Applicant | COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Contact | Charles Rose |
| Correspondent | Charles Rose COOPER LASERSONICS, INC. 3420 Central Expressway Santa Clara, CA 95051 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-09-23 |
| Decision Date | 1983-12-21 |