FDA.reportPublic FDA data

LUMENIS, LTD.

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
30041351913004135191LUMENIS, LTD.1N2020-04-256 HAKIDMA STREET PO BOX 240 YOKNEAM INDUSTRIAL PARK YOKNEAM Ha Zafon IL 2069204

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
2969291400130388K260100MOSES Raydar™GEX2026-05-18
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
2969291044620460K203544UltraPulse Surgical and Aesthetic CO2 Laser System, Delivery Devices and AccessoriesGEX2020-12-24
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
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
156601345659122K170060M22 and ResurFx SystemsGEX2017-08-09
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
156602022469672K151109Lumenis Smart532 Laser SystemGEX2015-10-30
156601881870367K130164FIBERLASE ENDURE CO2 FIBERGEX2013-03-24
2969291974815798K130164FIBERLASE ENDURE CO2 FIBERGEX2013-03-24
2969291043912630K100384FIBERLASE C02 LASER WAVEGUIDEGEX2010-04-12
156601773166275K100384FIBERLASE C02 LASER WAVEGUIDEGEX2010-04-12
156601196124289K100228VERSAPULSE MODEL P20 LASER SYSTEMGEX2010-02-24
156601855329357K053628LIGHTSHEER DUET LASER SYSTEMGEX2006-04-07
156601099931005K050639LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEMGCJ2005-03-31
2969292010043548K050639LUMENIS VERSACUT TISSUE MORCELLATOR SYSTEMGCJ2005-03-31
156601358759564K030147LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERSGEX2003-04-15
156601789212667K011703LUMENIS VERSAPULSE POWERSUITE HOLMIUM (HO:YAG) AND DUAL WAVELENGTH (HO:YAG/ND:YAG) SURGICAL LASERS AND DELIVERY DEVICESGEX2001-08-29

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX212026-05-18
GCJ22005-03-31

PMN#