Applicator 1

GUDID 07290016586770

POLLOGEN LTD

Radio-frequency skin surface treatment system applicator
Primary Device ID07290016586770
NIH Device Record Keya9447b15-d80e-4ad6-bb71-03519bb23874
Commercial Distribution StatusIn Commercial Distribution
Brand NameApplicator 1
Version Model Number20900340BK
Company DUNS514905681
Company NamePOLLOGEN LTD
Device Count1
DM Exemptfalse
Pre-market Exempttrue
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
GS107290016586770 [Primary]
GS117290016586777 [Package]
Package: [1 Units]
In Commercial Distribution

FDA Product Code

GEIElectrosurgical, Cutting & Coagulation & Accessories

Sterilization

Steralize Prior To Usefalse
Device Is Sterilefalse

Device Entry Metadata

Public Version StatusNew
Device Record StatusPublished
Public Version Number1
Public Version Date2026-02-10
Device Publish Date2026-02-02

Devices Manufactured by POLLOGEN LTD

07290016586565 - Applicator 32026-02-10
07290016586572 - Applicator VO2026-02-10
07290016586763 - triLift FACE2026-02-10 The device is a software-controlled capital equipment platform that enables application of radiofrequency (RF) energy onto the s
07290016586770 - Applicator 12026-02-10
07290016586770 - Applicator 12026-02-10
07290016586787 - Applicator 22026-02-10
07290016586671 - GENEO, GLO2FACIAL, ELITE2025-02-19 RF PRO handpiece kit (formerly branded "TriPollar RF Applicator" kit) for GENEO X system (formerly branded "ELITE") in its USA C
07290016586459 - Desire model U2023-12-25 TRIPOLLAR DESIRE PACKED ROSE GOLD USA
07290016586626 - STOP VX2 MODEL U 2023-12-22

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