The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for #6000 Nd:yag Laser System Urology/gastrointestinal.
| Device ID | K861903 |
| 510k Number | K861903 |
| Device Name: | #6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL |
| 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 | 1986-05-16 |
| Decision Date | 1986-06-20 |