The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Coherent Ultrapulse S Series Co2 Surgical Lasers Model C And L.
Device ID | K974789 |
510k Number | K974789 |
Device Name: | COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L |
Classification | Powered Laser Surgical Instrument |
Applicant | LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto, CA 94303 -0810 |
Contact | Michele Deeton |
Correspondent | Michele Deeton 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 | 1997-12-22 |
Decision Date | 1998-03-09 |
Summary: | summary |