The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Coherent Family Of Co2 Surgical Laser Scanner Handpieces.
Device ID | K946304 |
510k Number | K946304 |
Device Name: | COHERENT FAMILY OF CO2 SURGICAL LASER SCANNER HANDPIECES |
Classification | Powered Laser Surgical Instrument |
Applicant | LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto, CA 94303 -0810 |
Contact | Anne C Worden |
Correspondent | Anne C Worden LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto, CA 94303 -0810 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1994-12-28 |
Decision Date | 1995-03-15 |