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POLLOGEN LTD

FDA Registration(s)#

Registration, FEI, Name table
RegistrationFEINameStatusInitial importerExpiration yearAddress
30087532753008753275POLLOGEN LTD1N2026-01-016 Kaufman Street (main) Tel Aviv IL 6801298

Registered Device Listings#

Registration key, Listing key, Premarket submission table
Registration keyListing keyPremarket submissionDeviceProduct codeDecision date
1355961458036464K252576Legend X PlatformGEI2025-09-12
1355961789229073K243217Legend X Desktop SystemGEI2024-11-01
1355961834031500K242227GENEO X ELITEPAY2025-10-12
1355962005705047K240999Legend X Applicator VOGEI2024-05-08
1355961346077737K233766Geneo X ElitePAY2024-05-07
1355961373919389K232903Legend X PlatformGEI2023-10-17
1355961097672150K220322Pollogen STOP U Model UXV DevicePAY2023-05-04
1355961839332033K203665STOP U Model UXV DevicePAY2021-02-25
1355961228854793K200545Legend Pro DMANGX2021-10-21
1355961271473565K182774STOP U (Packed Black USA), STOP U (Packed White USA)PAY2019-06-19
1355961814784438K173503Pollogen Legend SystemGEI2018-06-11
1355961992252200K171359Pollogen Legend+ SystemGEI2017-09-13
1355961044051972K140255STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA)GEI2014-05-14
1355961066234925
1355961902639788

Product Codes Associated With Registrations#

Product code, Registration listing records, Latest decision table
Product codeRegistration listing recordsLatest decision
GEI72025-09-12
PAY52025-10-12
NGX12021-10-21

PMN#

GUDID#

POLLOGEN LEGEND - The Pollogen Legend+ system is intended for dermatological procedures requiring ablation and resurfacing of the skin when using VoluDerm Energy (Applicator VO). It is also intended for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides when using TriPollar RF Energy (Applicators 1-3). Pollogen Legend+ system is composed of a console, VO hand held applicator and disposable tips, designed to deliver bipolar radiofrequency electrical current to the skin surface, via an array of multi-electrode pins. It is also composed of 3 treatment applicators, foot switch and patient-controlled manual switch. User interface allows the selection of treatment parameters: applicator, power and time and displays the current settings. The RF module provides RF energy to applicators at 1 MHz frequency. The treatment applicators transmit Bi-Polar RF energy through multiple electrode configuration which produces homogenous heating of the treatment area.

POLLOGEN LTD

2017-04-06

Legend Pro - LEGEND PRO PACKEDApplicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. Applicator No. 1 is indicated for the treatment of large facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, consists of a plastic body with an integrated electronic system, 6 electrodes and indication light guide ring.

POLLOGEN LTD

2019-05-12

Legend Pro - LP APPLICATOR 1Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. Applicator No. 1 is indicated for the treatment of large facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, consists of a plastic body with an integrated electronic system, 6 electrodes and indication light guide ring.

POLLOGEN LTD

2019-05-12

Legend Pro - LP APPLICATOR 2 Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. Applicator No. 1 is indicated for the treatment of large facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, consists of a plastic body with an integrated electronic system, 6 electrodes and indication light guide ring.

POLLOGEN LTD

2019-05-12

Legend Pro - LP APPLICATOR 3Applicators 1-3 provide RF energy that heats biological tissue in a controlled fashion for non-ablative therapeutic effects. Non ablative effects are used to trigger collagen remodeling for the treatment of wrinkles and rhytides. Applicator No. 1 is indicated for the treatment of large facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, consists of a plastic body with an integrated electronic system, 6 electrodes and indication light guide ring.

POLLOGEN LTD

2019-05-12

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