The following data is part of a premarket notification filed by Lumenis, Ltd. with the FDA for Q-switched Nd:yag Laser Treatment Head For The Lumenis Quantum Series.
Device ID | K043173 |
510k Number | K043173 |
Device Name: | Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES |
Classification | Powered Laser Surgical Instrument |
Applicant | LUMENIS, LTD. 2400 CONDENSA ST. Santa Clara, CA 95051 |
Contact | Martha Murari |
Correspondent | Martha Murari 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 | 2004-11-16 |
Decision Date | 2005-01-31 |
Summary: | summary |