The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for Model 920 Argon/dye Laser-for Dermatological/use.
Device ID | K852860 |
510k Number | K852860 |
Device Name: | MODEL 920 ARGON/DYE LASER-FOR DERMATOLOGICAL/USE |
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 | 1985-07-08 |
Decision Date | 1985-10-07 |