The following data is part of a premarket notification filed by Coherent Medical Group with the FDA for Ultrapulse(tm) Carbon Dioxide Surgical Laser.
Device ID | K912029 |
510k Number | K912029 |
Device Name: | ULTRAPULSE(TM) CARBON DIOXIDE SURGICAL LASER |
Classification | Powered Laser Surgical Instrument |
Applicant | COHERENT MEDICAL GROUP 3270 W. BAYSHORE RD. P.O. BOX 10122 Palo Alto, CA 94303 |
Contact | Virginia Singer |
Correspondent | Virginia Singer 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 | 1991-05-07 |
Decision Date | 1991-08-13 |