The following data is part of a premarket notification filed by Lumenis, Inc. with the FDA for Coherent Versapulse 2.1u /1.06u Compact Surgical Laser, Models A & B.
Device ID | K933318 |
510k Number | K933318 |
Device Name: | COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B |
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 | 1993-07-19 |
Decision Date | 1994-07-08 |