|
Device Name
|
Applicant
|
510(K) Number
|
Decision Date
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opusduo; opusduo e; opusduo ec; opus 20; opus spectrum
|
LUMENIS LTD.
|
K040270 |
12/16/2004
|
q-switched nd:yag laser treatment head for the lumenis quantum series
|
LUMENIS, LTD.
|
K043173 |
01/31/2005
|
quantum, models sr, hr, dl; vasculight, models sr, hr, vs, vx, dl
|
LUMENIS, INC.
|
K020839 |
10/11/2002
|
selecta 7000 frequency doubled, q-switched nd:yag ophthalmic laser
|
LUMENIS, INC.
|
K004006 |
03/26/2001
|
selecta family of ophithalmic laser systems
|
LUMENIS, INC.
|
K081704 |
09/11/2008
|
smart laser indirect ophthalmoscope (lio); laser delivery device for lumenis novus spectra laser system, lumenis vision one laser system, and lumenis smart532™ laser system
|
LUMENIS LTD
|
K162837 |
02/28/2017
|
stellar m22 for intense pulsed light (ipl) and laser system
|
Lumenis Ltd.
|
K193500 |
01/16/2020
|
the family of ultrapulse co2 surgical and aesthetic lasers, delivery devices and accessories
|
Lumenis Be, Ltd.
|
K220467 |
05/18/2022
|
the ultrapulse system (ultrapulse and ultrapulse duo models,members of the modified lumenis family of ultrapulse surgitouch
|
LUMENIS LTD
|
K151331 |
06/30/2015
|
ultrapulse alpha co2 laser system, delivery devices and accessories
|
Lumenis Be Ltd.
|
K233301 |
12/01/2023
|
|