Automatic Eye Safety Filter

GUDID 00810096330284

Lumenis Be, Inc.

Laser filter, optical
Primary Device ID00810096330284
NIH Device Record Key307d3b75-ebc9-4cdc-aff3-e63a8d94c73d
Commercial Distribution StatusIn Commercial Distribution
Brand NameAutomatic Eye Safety Filter
Version Model NumberAutomatic Eye Safety Filter 532nm
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
GS100810096330284 [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 Date2023-04-10
Device Publish Date2023-04-02

On-Brand Devices [Automatic Eye Safety Filter]

00810096330307Automatic Eye Safety Filter 532/577/659 nm
00810096330284Automatic Eye Safety Filter 532nm

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