LaserLink S

GUDID 00810096330345

Lumenis Be, Inc.

Ophthalmic solid-state laser system
Primary Device ID00810096330345
NIH Device Record Keyf89dae66-24e0-4de6-9d10-854bf1b950af
Commercial Distribution StatusIn Commercial Distribution
Brand NameLaserLink S
Version Model NumberNA
Company DUNS118292380
Company NameLumenis Be, 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
GS100810096330345 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

HQFLaser, Ophthalmic

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2023-04-10
Device Publish Date2023-04-02

Devices Manufactured by Lumenis Be, Inc.

00810096330000 - Selecta Duet™2023-05-22
00810096330017 - Digital Duet™2023-05-22
00810096330024 - Smart-V Illumination Add-on2023-05-22
00810096330062 - Smart5322023-04-10
00810096330079 - Array LaserLink2023-04-10
00810096330086 - Vision One2023-04-10
00810096330093 - Vision One2023-04-10
00810096330109 - Vision One2023-04-10

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