Rosacea I-III Filter

GUDID 07290109144900

LUMENIS LTD.

Intense pulsed light dry eye therapy unit
Primary Device ID07290109144900
NIH Device Record Key66a5aefe-310a-4199-a00f-7aff13a1d6ab
Commercial Distribution StatusIn Commercial Distribution
Brand NameRosacea I-III Filter
Version Model NumberRosacea I-III Filter
Company DUNS600166524
Company NameLUMENIS LTD.
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 Batchtrue
Serial Numberfalse
Manufacturing Datefalse
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
GS107290109144900 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

QIUIntense Pulsed Light Device For Managing Dry Eye

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2021-08-02
Device Publish Date2021-07-25

Devices Manufactured by LUMENIS LTD.

07290109147161 - Lumenis Pulse 120H2025-02-26
07290109147178 - Lumenis Pulse 120H2025-02-26
07290109147185 - Lumenis Pulse, Moses 2.0 (DOM)2025-02-26
07290109147192 - Lumenis Pulse 120H2025-02-26
07290109147208 - Lumenis Pulse, Moses 2.0 (INT)2025-02-26
07290109147215 - Lumenis Pulse 120H2025-02-26
07290109147222 - Lumenis Pulse 120H2025-02-26
07290109147291 - Lumenis Pulse 120H2025-02-26

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