Q-Switched Nd:YAG Disposable Tips Spot size 2.5mm

GUDID 07290117770351

LUMENIS BE LTD

Multi-modality skin surface treatment system
Primary Device ID07290117770351
NIH Device Record Key45c70b77-b5eb-4fce-bc23-b9edc4be5320
Commercial Distribution StatusIn Commercial Distribution
Brand NameQ-Switched Nd:YAG Disposable Tips Spot size 2.5mm
Version Model NumberQ-Switched Nd:YAG Disposable Tips Spot size 2.5mm
Company DUNS600763501
Company NameLUMENIS BE LTD
Device Count30
DM Exemptfalse
Pre-market Exemptfalse
MRI Safety StatusLabeling does not contain MRI Safety Information
Human Cell/Tissue Productfalse
Device Kitfalse
Device Combination Productfalse
Single Usetrue
Lot Batchtrue
Serial Numberfalse
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
GS107290117770351 [Unit of Use]
GS117290117770648 [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 Date2023-08-10
Device Publish Date2023-08-02

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
07290117772416 - LUSTER Tip, Round2024-01-30
17290117772420 - OPT™ Shields2024-01-03
07290117771372 - AcuPulse2023-12-12

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