Lumenis Ltd

FDA Filings

This page includes the latest FDA filings for Lumenis Ltd. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Lumenis Ltd.
Stellar M22 For Intense Pulsed Light (IPL) And Laser System2020-01-16
Lumenis Ltd.
AcuPulse (previously Called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUO2018-04-03
Lumenis Ltd.
LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer Infinity2017-09-18
LUMENIS, LTD.
M22 And ResurFx Systems2017-08-09
Lumenis Ltd.
Lumenis Family Of Holmium Surgical Lasers And Delivery Devices And Accessories2017-05-22
LUMENIS LTD
Smart Laser Indirect Ophthalmoscope (LIO); Laser Delivery Device For Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, And Lumenis Smart532™ Laser System2017-02-28
LUMENIS, INC.
Lumenis Smart532 Laser System2015-10-30
LUMENIS LTD
LightSheer Desire Light Laser System2015-08-12
LUMENIS LTD
The UltraPulse System (UltraPulse And UltraPulse DUO Models,members Of The Modified Lumenis Family Of UltraPulse SurgiTouch2015-06-30
Lumenis Ltd.
Lumenis M22 System2015-01-21
LUMENIS LTD.
VERSACUT + TISSUE MORCELLATOR2014-05-13
LUMENIS LTD.
ET LIGHTSHEER 1060, HIGH SPEED LIGHTSHEER 10602014-03-20
LUMENIS LTD.
LUMENIS PULSE 120H2014-03-14
LUMENIS, INC.
SCANNING LASERLINK2013-11-01
LUMENIS, LTD.
RESURFX 1565NM LASER MODULE2013-09-03
LUMENIS LTD.
FIBERLASE ENDURE CO2 FIBER2013-03-24
LUMENIS INC.
VISION ONE LASER SYSTEM2011-07-25
LUMENIS
ACUPULSE 30/40 ST CO2 LASER SYSTEM AND ACUPULSE 40WG CO2 LASER SYSTEM2010-04-21
LUMENIS, LTD.
FIBERLASE C02 LASER WAVEGUIDE2010-04-12
LUMENIS, INC.
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS2008-09-11
LUMENIS, INC.
LIGHTSHEER DUET LASER SYSTEM2006-04-07
LUMENIS, INC.
LUMENIS 1000 INTEGRATED SLIT LAMP2005-08-30
LUMENIS, INC.
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM2005-03-31
LUMENIS LTD.
OPUSDUO; OPUSDUO E; OPUSDUO EC; OPUS 20; OPUS SPECTRUM2004-12-16
LUMENIS, LTD.
LUMENIS FAMILY OF IPL SYSTEMS AND COMBINATION IPL/ND:YAG SYSTEMS2003-07-17
LUMENIS
LUMENIS FAMILY OF IPL AND COMBINATION IPL/ND:YAG SYSTEMS2003-05-20
LUMENIS, INC.
NOVUS SPECTRA2002-10-16
LUMENIS, INC.
NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES2002-10-01
LUMENIS, INC.
SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASER2001-03-26
LUMENIS, INC.
COHERENT LASERLINK Z-1000 SLIT LAMP LASER DELIVERY ADAPTER2000-03-13

Latest Premarket Applications

PMAManufacturerDevice NameDate
LUMENIS
COHERENT OPAL PHOTOACTIVATOR2001-09-27
LUMENIS
COHERENT OPAL PHOTOACTIVATOR LASER SYSTEM2000-04-12
LUMENIS, INC.
COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS1998-12-23
LUMENIS, INC.
COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS1998-11-24
LUMENIS, INC.
COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS1998-01-09
LUMENIS, INC.
COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS1995-12-27

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
Stellar M22 Q-switched Nd:YAG upgrade
LUMENIS LTD.2020-02-11
Stellar M22 Multi-Spot Nd:YAG upgrade
LUMENIS LTD.2020-02-11
SurgiTouch™ Upgrade kit for UltraPulse®
LUMENIS LTD.2019-11-08
SurgiTouch™ Upgrade kit for UltraPulse® SurgiTouch™
LUMENIS LTD.2019-11-08
SurgiTouch™ Upgrade kit for UltraPulse® SurgiTouch™
LUMENIS LTD.2019-11-08
SurgiTouch™ Upgrade kit for UltraPulse® SurgiTouch™
LUMENIS LTD.2019-11-08
SurgiTouch™ Upgrade kit for UltraPulse®
LUMENIS LTD.2019-11-08
MicroSwitch Joystick
LUMENIS LTD.2019-11-08
UltraPulse® Focused Incisional Handpiece Set
LUMENIS LTD.2019-11-08
UltraScan™ CPG
LUMENIS LTD.2019-11-08
UltraPulse® Focused Incisional Handpiece Set
LUMENIS LTD.2019-11-08
Multi-Application Handpiece Set
LUMENIS LTD.2019-11-08
Acculite EndoOto
LUMENIS INC.2019-06-14
Acculite EndoOto
LUMENIS INC.2019-06-14
Lumenis 1000 Integrated Slit Lamp
LUMENIS INC.2019-05-03
Lumenis 1000 Integrated Slit Lamp
LUMENIS INC.2019-05-03
LightSheer Duet
LUMENIS LTD.2019-05-02
ENDURE™ sterilization tray
LUMENIS LTD.2019-04-29
OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™
LUMENIS LTD.2019-04-29
OtoLase™ Straight HP
LUMENIS LTD.2019-04-29
OtoLase™ Curved HP
LUMENIS LTD.2019-04-29
OtoLase™ Starter Kit
LUMENIS LTD.2019-04-29
Slimline Sterilization Tray
LUMENIS LTD.2019-04-29
OtoScan™ Ear Aeration System for UltraPulse® SurgiTouch™
LUMENIS LTD.2019-04-29
AcuSpot 712 Z Micromanipulator
LUMENIS LTD.2019-04-29
AcuSpot 712 L Micromanipulator
LUMENIS LTD.2019-04-29
AcuSpot 712 Micromanipulator
LUMENIS LTD.2019-04-29
Multi-Application Handpiece Set 90° Mirror Tip
LUMENIS LTD.2019-04-29
Multi-Application Handpiece Set 120° Mirror Tip
LUMENIS LTD.2019-04-29
AcuPulse™ Incisional Handpiece 125 mm
LUMENIS LTD.2019-04-29
Laryngeal Probe Straight Tip 90 Degree Left Mirror Smoke Evacuation Channel
LUMENIS LTD.2019-04-29
Laryngeal Probe Straight Tip, 90 Degree Right Mirror Smoke Evacuation Channel
LUMENIS LTD.2019-04-29
Laryngeal Probe Straight Tip Smoke Evacuation Channel
LUMENIS LTD.2019-04-29
Laryngeal Probe Straight Tip
LUMENIS LTD.2019-04-29
Nasal Probe Coupler for Fiber Insert
LUMENIS LTD.2019-04-29

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