The following data is part of a premarket notification filed by Lumenis, Ltd. with the FDA for Modified Lumenis Family Of Intense Pulsed-light (ipl) And Combination Ipl Systems And Nd:yag Laser Systems.
Device ID | K024093 |
510k Number | K024093 |
Device Name: | MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS |
Classification | Powered Laser Surgical Instrument |
Applicant | LUMENIS, LTD. 2400 CONDENSA ST. Santa Clara, CA 95051 |
Contact | Anne Worden |
Correspondent | Anne Worden 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 | 2002-12-11 |
Decision Date | 2003-06-19 |
Summary: | summary |