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LUMENIS BE INC.

Matched from indexed company URL: Lumenis Be Ltd

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
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

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
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
2967301127635661K202428AcuPulse W CO2 Laser Systems, Delivery Devices and AccessoriesGEX2020-10-22
2967301059156707K193500Stellar M22 for Intense Pulsed Light (IPL) and Laser SystemGEX2020-01-16
2967301093320809K170179LightSheer Desire; LightSheer Desire Light; LightSheer Duet; LightSheer InfinityGEX2017-09-18
2967301286103646K170060M22 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
2967281781816263K151109Lumenis Smart532 Laser SystemGEX2015-10-30
2967281302129895K111213VISION ONE LASER SYSTEMGEX2011-07-25
2967301207856039K030147LUMENIS FAMILY OF ULTRAPULSE SURGITOUCH CO2 SURGICAL LASERSGEX2003-04-15
2967301061513085DEN200028Lumenis Stellar M22QIU2021-02-23
2967301626936014

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEX122025-04-16
OAP12023-06-14
HQF12022-07-15
QIU12021-02-23

PMN#

FoLix

2024-09-09

Lumenis Be, Ltd.

GUDID#

126 records. Showing 1-40. Next