Stellar M22™

GUDID 07290117770016

LUMENIS BE LTD

Multi-modality skin surface treatment system
Primary Device ID07290117770016
NIH Device Record Keyd535eafd-a600-482d-8d58-7fe5f5b80876
Commercial Distribution StatusIn Commercial Distribution
Brand NameStellar M22™
Version Model NumberStellar M22™ WIZ
Company DUNS600763501
Company NameLUMENIS BE 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 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
GS107290117770016 [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 Date2023-08-10
Device Publish Date2023-08-02

On-Brand Devices [Stellar M22™]

07290117770016Stellar M22™ WIZ
07290117772195Stellar M22™ RFX

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