The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Modified Coherent Ultrapulse Co2 Surgical Lasers.
Device ID | K951812 |
510k Number | K951812 |
Device Name: | MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS |
Classification | Powered Laser Surgical Instrument |
Applicant | LUMENIS, INC. 3270 WEST BAYSHORE RD. POST OFFICE BOX 10122 Palo Alto, CA 94303 -0810 |
Contact | Anne Worden |
Correspondent | Anne 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 | 1995-04-19 |
Decision Date | 1995-07-07 |