Smart-V Illumination Add-on

GUDID 07290109143637

LUMENIS INC.

Ophthalmic solid-state laser system
Primary Device ID07290109143637
NIH Device Record Key5b8235b3-d856-4c69-8aa5-847355fcd11d
Commercial Distribution StatusIn Commercial Distribution
Brand NameSmart-V Illumination Add-on
Version Model NumberSmart-V Illumination Add-on
Company DUNS043618763
Company NameLUMENIS INC.
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
GS107290109143637 [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 Date2022-03-31
Device Publish Date2022-03-23

Devices Manufactured by LUMENIS INC.

07290109140612 - Smart LIO2023-06-22
07290109143835 - Smart LIO2023-06-22
07290109143842 - Smart LIO2023-06-22
07290109143637 - Smart-V Illumination Add-on2022-03-31
07290109143637 - Smart-V Illumination Add-on2022-03-31
07290109145181 - Digital Duet2021-03-30
17290109140787 - Acculite EndoOcular2020-02-24
07290109140827 - Acculite EndoOto2020-02-24
17290109140831 - Acculite EndoOto2020-02-24

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