Stellar M22™ AES IPL Module Kit

GUDID 07290117770214

LUMENIS BE LTD

Multi-modality skin surface treatment system
Primary Device ID07290117770214
NIH Device Record Key5210b064-8a67-4343-9c71-f1af80392e88
Commercial Distribution StatusIn Commercial Distribution
Brand NameStellar M22™ AES IPL Module Kit
Version Model NumberStellar M22™ AES IPL Module Kit
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 Kittrue
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
GS107290117770214 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect

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

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