Acculite EndoOcular

GUDID 17290109140787

LUMENIS INC.

Ophthalmic laser system beam guide
Primary Device ID17290109140787
NIH Device Record Key81d0a691-4b33-41a8-b828-18baacd8ce68
Commercial Distribution Discontinuation2020-02-21
Commercial Distribution StatusNot in Commercial Distribution
Brand NameAcculite EndoOcular
Version Model NumberIllum/Sm Plug, 20ga str, SMA 906, 200µm
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 Usetrue
Lot Batchtrue
Serial Numberfalse
Manufacturing Datefalse
Expiration Datetrue
Donation Id Numberfalse
Contains Natural Rubber Latexfalse
Labeled No Natural Rubber Latexfalse
RX Perscriptiontrue
OTC Over-The-Counterfalse

Customer Support Contacts

Phone408-764-3000
Emailxxx@xxx.xxx

Device Identifiers

Device Issuing AgencyDevice ID
GS107290109140780 [Primary]
GS117290109140787 [Package]
Contains: 07290109140780
Package: [10 Units]
Discontinued: 2020-02-21
Not in Commercial Distribution

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usetrue
Device Is Steriletrue

[17290109140787]

Ethylene Oxide


Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number4
Public Version Date2020-02-24
Device Publish Date2016-09-25

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
07290109145181 - Digital Duet2021-03-30
17290109140787 - Acculite EndoOcular2020-02-24
17290109140787 - Acculite EndoOcular2020-02-24
07290109140827 - Acculite EndoOto2020-02-24
17290109140831 - Acculite EndoOto2020-02-24

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