IPL Upgrade Kit for Stellar Optima

GUDID 07290109145198

LUMENIS LTD.

Multi-modality skin surface treatment system
Primary Device ID07290109145198
NIH Device Record Key22c5078d-1f7c-4755-9370-e668861d2373
Commercial Distribution StatusIn Commercial Distribution
Brand NameIPL Upgrade Kit for Stellar Optima
Version Model NumberIPL Upgrade Kit for Stellar Optima
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 Kittrue
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
GS107290109145198 [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 Date2021-06-04
Device Publish Date2021-05-27

Devices Manufactured by LUMENIS LTD.

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07290109147291 - Lumenis Pulse 120H2025-02-26

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