Lumenis Inc

FDA Filings

This page includes the latest FDA filings for Lumenis Inc. Currently, you will find the latest 100 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Lumenis Inc holds import registrations or U.S. agent authorizations in conjunction with the following organizations:

FDA Registration(s)
Registration Number1720381
FEI Number1720381
NameLUMENIS, INC.
Owner & OperatorLUMENIS LTD
Contact Address6 Hakidma Street PO Box 240 Yokneam Industrial Park
Yokneam IL-NOTA 2069204 IL
Registration Status1
Initial ImporterY
Registration Expiration2020-04-25
Registration Address1870 S Milestone Dr
SALT LAKE CITY, UT 84104 US
Establishment Type
  • Develop Specifications But Do Not Manufacture At This Facility
  • Manufacture Medical Device



FDA Filings

Device
Company
DeviceDate
LUMENIS INC.
Smart LIO 2023-06-22
LUMENIS INC.
Smart LIO 2023-06-22
LUMENIS INC.
Smart LIO 2023-06-22
LUMENIS INC.
Smart-V Illumination Add-on 2022-03-31
LUMENIS INC.
Digital Duet 2021-03-30
LUMENIS INC.
Acculite EndoOto 2020-02-24
LUMENIS INC.
Acculite EndoOto 2020-02-24
LUMENIS INC.
Acculite EndoOcular 2020-02-24
LUMENIS INC.
Acculite EndoOto 2020-02-24
LUMENIS INC.
Acculite EndoOto 2020-02-24
LUMENIS INC.
Lumenis 1000 Integrated Slit Lamp 2019-05-03
LUMENIS INC.
Lumenis 1000 Integrated Slit Lamp 2019-05-03
LUMENIS INC.
Acculite™  EndoOcular® 2018-07-06
LUMENIS INC.
Acculite™  EndoOto™ 2018-07-06
LUMENIS INC.
Acculite™  EndoOcular® 2018-07-06
LUMENIS INC.
Acculite™  EndoOcular® 2018-07-06
LUMENIS INC.
Acculite™  EndoOcular® 2018-07-06
LUMENIS INC.
Acculite™  EndoOcular® 2018-07-06
LUMENIS INC.
Acculite™  EndoOcular® 2018-07-06
LUMENIS INC.
Acculite™  EndoOcular® 2018-07-06
LUMENIS INC.
LIO Keeler 2018-07-06
LUMENIS INC.
LIO Heine 2018-07-06
LUMENIS INC.
Array LaserLink 2018-07-06
LUMENIS INC.
Selecta Duet 2018-07-06
LUMENIS INC.
Selecta Duet 2018-07-06
LUMENIS INC.
Vision One 2018-07-06
LUMENIS INC.
Novus Spectra 2018-07-06
LUMENIS INC.
LaserLink S 2018-07-06
LUMENIS INC.
Selecta Duet 2018-07-06
LUMENIS INC.
Novus Spectra 2018-07-06
LUMENIS INC.
Selecta II 2018-07-06
LUMENIS INC.
Acculite™  EndoOcular® 2018-07-06
LUMENIS INC.
Acculite™  EndoOcular® 2018-07-06
LUMENIS INC.
Fixed Eye Safety Filter 2018-03-29
LUMENIS INC.
Fixed Eye Safety Filter 2018-03-29
LUMENIS INC.
Automatic Eye Safety Filter 2018-03-29
LUMENIS INC.
Automatic Eye Safety Filter 2018-03-29
LUMENIS INC.
LaserLink HS 2018-03-29
LUMENIS INC.
LaserLink Z 2018-03-29
LUMENIS INC.
SL130 Slit Lamp & Table 2018-03-29
LUMENIS INC.
Automatic Eye Safety Filter 2018-03-29
LUMENIS INC.
Automatic Eye Safety Filter 2018-03-29
LUMENIS INC.
Automatic Eye Safety Filter 2018-03-29
LUMENIS INC.
Automatic Eye Safety Filter 2018-03-29
LUMENIS INC.
Fixed Eye Safety Filter 2018-03-29
LUMENIS INC.
Fixed Eye Safety Filter 2018-03-29
LUMENIS INC.
Fixed Eye Safety Filter 2018-03-29
LUMENIS INC.
Fixed Eye Safety Filter 2018-03-29
LUMENIS INC.
Fixed Eye Safety Filter 2018-03-29
LUMENIS INC.
LaserLink HS 2018-03-29
LUMENIS INC.
Automatic Eye Safety Filter 2018-03-29
LUMENIS INC.
LaserLink Z 2018-03-29
LUMENIS INC.
LaserLink Z 2018-03-29
LUMENIS INC.
LIO Keeler 2018-03-29
LUMENIS INC.
Smart532 2018-03-29
LUMENIS, INC. [LUMENIS LTD]
Smart LIO2017-03-01
LUMENIS, INC. [LUMENIS LTD]
Smart5322015-11-03
LUMENIS, INC. [LUMENIS LTD]
LaserLink HS2015-11-03
LUMENIS, INC. [LUMENIS LTD]
Eye Safety Filter Kit2015-11-03
LUMENIS, INC. [LUMENIS LTD]
Array LaserLink2015-11-03
LUMENIS, INC.
Lumenis Smart532 Laser System2015-10-30
LUMENIS, INC. [LUMENIS LTD]
Array LaserLink2013-11-25
LUMENIS, INC.
SCANNING LASERLINK2013-11-01
LUMENIS, INC. [LUMENIS LTD]
Vision One2011-08-01
LUMENIS, INC. [LUMENIS LTD]
LaserLink Z2011-08-01
LUMENIS, INC. [LUMENIS LTD]
LaserLink HS2011-08-01
LUMENIS, INC. [LUMENIS LTD]
Eye Safety Filter Kit2011-08-01
LUMENIS INC.
VISION ONE LASER SYSTEM2011-07-25
LUMENIS, INC.
POLYSCOPE FLEXIBLE ENDOSCOPY CATHETER; 10,000 PIXEL FIBER OPTIC; XENON LIGHT SOURCE, MODEL LS-2002009-09-30
LUMENIS, INC.
ACUPULSE 30 AND 40 CARBON DIOXIDE LASER SYSTEM2008-12-18
LUMENIS, INC. [LUMENIS LTD]
Smart-V2008-11-11
LUMENIS, INC. [LUMENIS LTD]
Selecta Trio2008-11-11
LUMENIS, INC. [LUMENIS LTD]
Selecta Duet2008-11-11
LUMENIS, INC. [LUMENIS LTD]
LaserLink S2008-11-11
LUMENIS, INC. [LUMENIS LTD]
Smart-V2008-11-11
LUMENIS, INC. [LUMENIS LTD]
Selecta Trio2008-11-11
LUMENIS, INC. [LUMENIS LTD]
Selecta Duet2008-11-11
LUMENIS, INC. [LUMENIS LTD]
LaserLink S2008-11-11
LUMENIS, INC.
SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMS2008-09-11
LUMENIS, INC. [LUMENIS LTD]
Novus Spectra Laser System2008-04-18
LUMENIS, INC. [LUMENIS LTD]
Novus Spectra Dual Port Laser System2008-04-18
LUMENIS, INC. [LUMENIS LTD]
LaserLink Z2008-04-18
LUMENIS, INC. [LUMENIS LTD]
LaserLink HS2008-04-18
LUMENIS, INC. [LUMENIS LTD]
Eye Safety Filter Kit2008-04-18
LUMENIS, INC. [LUMENIS LTD]
Selecta II2008-04-18
LUMENIS, INC. [LUMENIS LTD]
Selecta II2008-04-18
LUMENIS, INC.
LIGHTSHEER DUET LASER SYSTEM2006-04-07
LUMENIS, INC.
FAMILY OF SELECTA LASER SYSTEMS INCLUDING SELECTA 1064, SELECTA SLT, SELECTA DUET, SELECTA DUO, SELECTA TRIO2006-03-09
LUMENIS, INC.
NOVUS 3000 LASER SYSTEM AND DELIVERY DEVICES2005-11-15
LUMENIS, INC.
ALUMA SKIN RENEWAL SYSTEM2005-10-24
LUMENIS, INC.
FAMILY OF SELECTA OPHTHALMIC LASER SYSTEMS (SELECTA 1064, SELECTA SLT, SELECTA DUO), DELIVERY DEVICE AND ACCESSORIES2005-09-30
LUMENIS, INC.
LUMENIS 1000 INTEGRATED SLIT LAMP2005-08-30
LUMENIS, INC.
LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEM2005-03-31
LUMENIS, INC.
NOVUS TTX LASER AND DELIVERY DEVICES WITH ACCESSORIES2003-10-09
LUMENIS, INC.
LUMENIS ULTRAPULSE ENCORE CARBON DIOXIDE SURGICAL LASERS AND DELIVERY DEVICE ACCESSORIES2002-10-30
LUMENIS, INC.
NOVUS SPECTRA2002-10-16
LUMENIS, INC.
QUANTUM, MODELS SR, HR, DL; VASCULIGHT, MODELS SR, HR, VS, VX, DL2002-10-11
LUMENIS, INC.
NOVUS VARIA OPHTHALMIC LASER AND DELIVERY DEVICES WITH ACCESSORIES2002-10-01
LUMENIS, INC.
BCLEAR2002-08-23
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
LUMENIS, INC.
NOVUS VERDI DELIVERY SYSTEMS1999-05-13
LUMENIS, INC.
MODIFIED VERSAPULSE SELECT SINGLE WAVELENGTH, HO: YAG AND DUAL WAVELENGTH, HO: YAG/ND: YAG SURGICAL LASERS AND DELIVERY1999-04-27
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.
MODIFIED VERSAPULSE SELECT HO:YAG AND HO:YAG/ND:YAG LASERS1998-05-20
LUMENIS, INC.
COHERENT TISSUE MORCELLATOR KIT AND ACCESSORIES1998-04-09
LUMENIS, INC.
COHERENT ULTRAPULSE S SERIES CO2 SURGICAL LASERS MODEL C AND L1998-03-09
LUMENIS, INC.
COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS1998-01-09
LUMENIS, INC.
COHERENT POPEYE OPHTHALMIC LASER SYSTEM, COHERENT POPEYE OPHTHALMIC LASER SYSTEM IN COMBINATION WITH THE COHERENT ARGONS1997-12-09
LUMENIS, INC.
MODIFIED COHERENT VERSAPULSE AESTHETIC SURGICAL LASER1997-09-19
LUMENIS, INC.
COHERENT SLIMLINE SINGLE LUMEN ASPIRATION NEEDLE KIT1996-04-04
LUMENIS, INC.
COHERENT PDL1 AND PDL2 LAMBDA PLUS PHOTODYNAMIC LASERS1995-12-27
LUMENIS, INC.
MODIFIED COHERENT ULTRAPULSE CO2 SURGICAL LASERS1995-07-07
LUMENIS, INC.
COHERENT FAMILY OF CO2 SURGICAL LASER SCANNER HANDPIECES1995-03-15
LUMENIS, INC.
COHERENT VERSAPULSE 2.1U /1.06U COMPACT SURGICAL LASER, MODELS A & B1994-07-08
LUMENIS, INC.
COHERENT DIODE PHOTOCOAGULATOR1990-09-20
LUMENIS, INC.
COHERENT XA30/SP AND XA50 SURGICAL LASERS1990-07-26
LUMENIS, INC.
COHERENT HOLMIUM:YAG SURGICAL LASER1989-11-30
LUMENIS, INC.
COHERENT XA-50, X30/CW, XA30/SP SURGICAL LASERS1989-09-25
LUMENIS, INC.
MODEL 450XL CO2 SURGICAL LASER1982-03-08
LUMENIS, INC.
MODEL 900S INTRAOCULAR PROBE1981-11-16
LUMENIS, INC.
ARGON MICROSURIGAL PROTOCOLS1981-08-21
LUMENIS, INC.
COHERENT FLOUROTRON MASTER1981-06-16
LUMENIS, INC.
HAAG-STREIT SLIT LAMP 9001979-11-16

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