FDA.reportPublic FDA data

LUMENIS, LTD.

Matched from indexed company URL: Lumenis, Inc.

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30041351913004135191LUMENIS, LTD.1N2026-01-016 HAKIDMA STREET PO BOX 240 YOKNEAM INDUSTRIAL PARK YOKNEAM Northern IL 2069204
30206119641720381LUMENIS BE INC.1Y2026-01-011870 South Milestone Drive Salt Lake City UT US 84104
30213496263021349626Lumenis Be Ltd1N2026-01-019 Hakidma St, POB # 426 Yokneam Industrial Park Yokneam, Ha Zafon 2069236 Haifa IL 2069236
17203811720381LUMENIS, INC.1Y2020-04-251870 S Milestone Dr SALT LAKE CITY UT US 84104
30041351913004135191LUMENIS, LTD.1N2020-04-256 HAKIDMA STREET PO BOX 240 YOKNEAM INDUSTRIAL PARK YOKNEAM Ha Zafon IL 2069204

GUDID Contact Samples#

Sampled from matched GUDID device records for this company; this is not an exhaustive company contact directory.

Source GUDID, Product, Phone table
Source GUDIDProductPhoneEmail
07290109140261Slimline™ 200 D/F/L - Slimline 200 DFL Fiber408-764-3000xxx@xxx.xxx
07290109140278Xpeeda DSL Fiber408-764-3000xxx@xxx.xxx

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2969291007353196K252529Moses™ 200 D/F/L Laser Fiber (M0068130100); Moses™ 365 D/F/L Laser Fiber (M0068130110); Moses™ 550 D/F/L Laser Fiber (M0068130120)GEX2025-10-30
2967301164854271K250809Stellar M22GEX2025-04-16
2967301646129932K242349FoLixGEX2024-09-09
2967301929049257K233301ULTRApulse Alpha CO2 Laser System, Delivery Devices and AccessoriesGEX2023-12-01
2967301442195368K222790F65 Laser SystemOAP2023-06-14
2967281612946485K220877Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser SystemsHQF2022-07-15
2967301271668322K212703AcuPulse CO2 Laser System, Delivery Devices and AccessoriesGEX2021-10-19
2969291044620460K203544UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesGEX2020-12-24
2967301127635661K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesGEX2020-10-22
2967301059156707K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemGEX2020-01-16
156601295005223K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemGEX2020-01-16
2969291827451783K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOGEX2018-04-03
156602014086208K180597AcuPulse (previously called AcuPulse 30/40 ST); AcuPulse 40W G; AcuPulse DUOGEX2018-04-03
2967301093320809K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityGEX2017-09-18
156601539025886K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityGEX2017-09-18
156601531240212K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesGEX2017-05-22
2969291538349165K170121Lumenis Family of Holmium Surgical Lasers and Delivery Devices and AccessoriesGEX2017-05-22
2967301286103646K170060M22 and ResurFx SystemsGEX2017-08-09
156601345659122K170060M22 and ResurFx SystemsGEX2017-08-09
2967281152906462K162837Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser SystemGEX2017-02-28
156571871548197K162837Smart Laser Indirect Ophthalmoscope (LIO); Laser delivery device for Lumenis Novus Spectra Laser System, Lumenis Vision One Laser System, and Lumenis Smart532™ Laser SystemGEX2017-02-28
156601435351672K151331The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouchGEX2015-06-30
2969291754667837K151331The UltraPulse system (UltraPulse and UltraPulse DUO models,members of the modified Lumenis Family of UltraPulse SurgiTouchGEX2015-06-30
2967281781816263K151109Lumenis Smart532 Laser SystemGEX2015-10-30
156602022469672K151109Lumenis Smart532 Laser SystemGEX2015-10-30
156572022469672K151109Lumenis Smart532 Laser SystemGEX2015-10-30
156571049975379K130195SCANNING LASERLINKHQF2013-11-01
156601881870367K130164FIBERLASE ENDURE CO2 FIBERGEX2013-03-24
2969291974815798K130164FIBERLASE ENDURE CO2 FIBERGEX2013-03-24
156571201089207K111213VISION ONE LASER SYSTEMGEX2011-07-25
2967281302129895K111213VISION ONE LASER SYSTEMGEX2011-07-25
2969291043912630K100384FIBERLASE C02 LASER WAVEGUIDEGEX2010-04-12
156601773166275K100384FIBERLASE C02 LASER WAVEGUIDEGEX2010-04-12
156601196124289K100228VERSAPULSE MODEL P20 LASER SYSTEMGEX2010-02-24
156571049606527K081704SELECTA FAMILY OF OPHITHALMIC LASER SYSTEMSGEX2008-09-11
156601855329357K053628LIGHTSHEER DUET LASER SYSTEMGEX2006-04-07
156601099931005K050639LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEMGCJ2005-03-31
2969292010043548K050639LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEMGCJ2005-03-31
2967301207856039K030147LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERSGEX2003-04-15
156601358759564K030147LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERSGEX2003-04-15
156571726182248K022327NOVUS SPECTRAGEX2002-10-16
156601789212667K011703LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICESGEX2001-08-29
156571425721076K004006SELECTA 7000 FREQUENCY DOUBLED, Q-SWITCHED ND:YAG OPHTHALMIC LASERGEX2001-03-26
2967301061513085DEN200028Lumenis Stellar M22QIU2021-02-23
2967301626936014

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX382025-10-30
HQF22022-07-15
GCJ22005-03-31
OAP12023-06-14
QIU12021-02-23

PMA#

PMN#

FoLix

2024-09-09

Lumenis Be, Ltd.

81 records. Showing 1-40. Next

GUDID#

146 records. Showing 1-40. Next