The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for Model 451 Co2 Surgical Laser.
| Device ID | K852190 |
| 510k Number | K852190 |
| Device Name: | MODEL 451 CO2 SURGICAL LASER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
| Contact | Len Goldfine |
| Correspondent | Len Goldfine COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-05-22 |
| Decision Date | 1985-08-23 |