LUSTER Handpiece

GUDID 07290117772409

LUMENIS BE LTD

Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system Dermatological solid-state laser system
Primary Device ID07290117772409
NIH Device Record Key1ed5be68-91e5-44b8-b2b7-4c31f0ee9f56
Commercial Distribution StatusIn Commercial Distribution
Brand NameLUSTER Handpiece
Version Model NumberNA
Company DUNS600763501
Company NameLUMENIS BE LTD
Device Count1
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usefalse
Lot Batchfalse
Serial Numbertrue
Manufacturing Datetrue
Expiration Datefalse
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Device Identifiers

Device Issuing AgencyDevice ID
GS107290117772409 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEXPowered Laser Surgical Instrument

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2024-01-30
Device Publish Date2024-01-22

Devices Manufactured by LUMENIS BE LTD

07290117772447 - FoLiCool™ Tip2024-03-25
07290117772522 - FoLix™2024-03-25
07290117772539 - FoLix™ Handpiece2024-03-25
07290117772393 - LUSTER System2024-01-30
07290117772409 - LUSTER Handpiece2024-01-30
07290117772409 - LUSTER Handpiece2024-01-30
07290117772416 - LUSTER Tip, Round2024-01-30
17290117772420 - OPT™ Shields2024-01-03
07290117771372 - AcuPulse2023-12-12

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