The following data is part of a premarket notification filed by Cooper Lasersonics, Inc. with the FDA for Model Ls 860, Co2 Laser.
| Device ID | K864562 |
| 510k Number | K864562 |
| Device Name: | MODEL LS 860, CO2 LASER |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent For Some Indications (SN) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-11-19 |
| Decision Date | 1987-04-09 |