POLLOGEN LEGEND 21400270

GUDID 07290016586022

Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are

POLLOGEN LTD

Radio-frequency skin surface treatment system
Primary Device ID07290016586022
NIH Device Record Keyf1b35f21-725e-433c-902b-786d609ca17b
Commercial Distribution StatusIn Commercial Distribution
Brand NamePOLLOGEN LEGEND
Version Model NumberPOLLOGEN LEGEND+
Catalog Number21400270
Company DUNS514905681
Company NamePOLLOGEN LTD
Device Count1
DM Exempttrue
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 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
GS107290016586022 [Primary]

FDA Pre-market Approvals/Notifications & deNovo

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusUpdate
Device Record StatusPublished
Public Version Number3
Public Version Date2018-07-06
Device Publish Date2017-04-06

On-Brand Devices [POLLOGEN LEGEND]

07290016586046The Pollogen Legend+ VO hand piece is designed to deliver radiofrequency energy to the skin in a
07290016586039Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-a
07290016586022Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-a
07290016586015Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-a
07290016586008The Pollogen Legend+ system is intended for dermatological procedures requiring ablation and res

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