FDA 510(k) Applications Submitted by LUMENIS, LTD.
| FDA 510(k) Number |
Submission Date |
Device Name |
Applicant |
| K100384 |
02/16/2010 |
FIBERLASE C02 LASER WAVEGUIDE |
LUMENIS, LTD. |
| K030342 |
02/03/2003 |
LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS |
LUMENIS, LTD. |
| K030147 |
01/15/2003 |
LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS |
LUMENIS, LTD. |
| K030033 |
01/03/2003 |
LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES |
LUMENIS, LTD. |
| K024093 |
12/11/2002 |
MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS |
LUMENIS, LTD. |
| K083733 |
12/16/2008 |
LUME 2 SYSTEM, MODEL GA0005000 |
LUMENIS, LTD. |
| K043173 |
11/16/2004 |
Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES |
LUMENIS, LTD. |
| K170060 |
01/06/2017 |
M22 and ResurFx Systems |
LUMENIS, LTD. |
| K212703 |
08/26/2021 |
AcuPulse CO2 Laser System, Delivery Devices and Accessories |
Lumenis, Ltd. |
| K130028 |
01/03/2013 |
RESURFX 1565NM LASER MODULE |
LUMENIS, LTD. |
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