Stellar M22™ ResurFX™ Module Upgrade Kit

GUDID 07290117770191

LUMENIS BE LTD

Dermatological laser beam guiding handpiece
Primary Device ID07290117770191
NIH Device Record Keya8dedcfe-be3d-416e-81e6-871f77c9716f
Commercial Distribution StatusIn Commercial Distribution
Brand NameStellar M22™ ResurFX™ Module Upgrade Kit
Version Model NumberNA
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
GS107290117770191 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

ONGPowered Laser Surgical Instrument With Microbeam\Fractional Output

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

Devices Manufactured by LUMENIS BE LTD

07290117772447 - FoLiCool™ Tip2024-03-25
07290117772522 - FoLix™2024-03-25
07290117772539 - FoLix™ Handpiece2024-03-25
07290117772393 - LUSTER System2024-01-30
07290117772409 - LUSTER Handpiece2024-01-30
07290117772416 - LUSTER Tip, Round2024-01-30
17290117772420 - OPT™ Shields2024-01-03
07290117771372 - AcuPulse2023-12-12

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