The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Coherent Holmium:yag Surgical Laser.
Device ID | K895518 |
510k Number | K895518 |
Device Name: | COHERENT HOLMIUM:YAG SURGICAL LASER |
Classification | Powered Laser Surgical Instrument |
Applicant | LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto, CA 94303 -0810 |
Contact | Virginia Singer |
Correspondent | Virginia Singer 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 | 1989-09-12 |
Decision Date | 1989-11-30 |