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 |