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Lumenis, Ltd.

28 FDA 510(k) clearances · Manufacturer

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RecordFirmDate
AcuPulse CO2 Laser System, Delivery Devices and Accessories (K212703)Lumenis, Ltd.2021-10-19
Lumenis Stellar M22 (DEN200028)Lumenis, Ltd.2021-02-23
UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and Accessories (K203544)Lumenis, Ltd.2020-12-24
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (K202428)Lumenis, Ltd.2020-10-22
AcuPulse W CO2 Laser Systems, Delivery Devices and Accessories (K201663)Lumenis, Ltd.2020-07-16
Stellar M22 for Intense Pulsed Light (IPL) and Laser System (K193500)Lumenis, Ltd.2020-01-16
AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO (K180597)Lumenis, Ltd.2018-04-03
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity (K170179)Lumenis, Ltd.2017-09-18
M22 and ResurFx Systems (K170060)Lumenis, Ltd.2017-08-09
Lumenis Family of Holmium Surgical Lasers and Delivery Devices and Accessories (K170121)Lumenis, Ltd.2017-05-22
Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser System (K162837)Lumenis, Ltd.2017-02-28
LightSheer Desire Light Laser System (K151947)Lumenis, Ltd.2015-08-12
The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouch (K151331)Lumenis, Ltd.2015-06-30
Lumenis M22 System (K142860)Lumenis, Ltd.2015-01-21
VERSACUT + TISSUE MORCELLATOR (K133272)Lumenis, Ltd.2014-05-13
ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 1060 (K133319)Lumenis, Ltd.2014-03-20
LUMENIS PULSE 120H (K140388)Lumenis, Ltd.2014-03-14
RESURFX 1565NM LASER MODULE (K130028)Lumenis, Ltd.2013-09-03
FIBERLASE ENDURE CO2 FIBER (K130164)Lumenis, Ltd.2013-03-24
FIBERLASE C02 LASER WAVEGUIDE (K100384)Lumenis, Ltd.2010-04-12
LUME 2 SYSTEM, MODEL GA0005000 (K083733)Lumenis, Ltd.2009-05-04
LUMENIS ONE FAMILY OF SYSTEMS; LUMENIS ONE. (K060448)Lumenis, Ltd.2006-07-06
Q-SWITCHED ND:YAG LASER TREATMENT HEAD FOR THE LUMENIS QUANTUM SERIES (K043173)Lumenis, Ltd.2005-01-31
OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM (K040270)Lumenis, Ltd.2004-12-16
LUMENIS FAMILY OF DISPOSABLE CONTACT TIP DELIVERY DEVICES (K030033)Lumenis, Ltd.2003-07-21
LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS (K030342)Lumenis, Ltd.2003-07-17
MODIFIED LUMENIS FAMILY OF INTENSE PULSED-LIGHT (IPL) AND COMBINATION IPL SYSTEMS AND ND:YAG LASER SYSTEMS (K024093)Lumenis, Ltd.2003-06-19
LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERS (K030147)Lumenis, Ltd.2003-04-15

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