The following data is part of a premarket notification filed by Lumenis, Ltd. with the FDA for Lumenis Family Of Ipl Systems And Combination Ipl/nd:yag Systems.
Device ID | K030342 |
510k Number | K030342 |
Device Name: | LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS |
Classification | Powered Laser Surgical Instrument |
Applicant | LUMENIS, LTD. 2400 CONDENSA ST. Santa Clara, CA 95051 |
Contact | Andrea L Ruth |
Correspondent | Andrea L Ruth LUMENIS, LTD. 2400 CONDENSA ST. Santa Clara, CA 95051 |
Product Code | GEX |
CFR Regulation Number | 878.4810 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2003-02-03 |
Decision Date | 2003-07-17 |
Summary: | summary |