Fixed Eye Safety Filter

GUDID 00810096330314

Lumenis Be, Inc.

Laser filter, optical
Primary Device ID00810096330314
NIH Device Record Key67566857-861a-46c3-988d-e06259a47629
Commercial Distribution StatusIn Commercial Distribution
Brand NameFixed Eye Safety Filter
Version Model NumberFixed Eye Safety Filter 532/577/659 nm
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
GS100810096330314 [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 [Fixed Eye Safety Filter]

00810096330314Fixed Eye Safety Filter 532/577/659 nm
00810096330291Fixed Eye Safety Filter 532 nm

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