FDA.reportPublic FDA data

POLLOGEN LTD

Matched from indexed company URL: 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#

Legend Pro - LEGEND PRO PACKED 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 1 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 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 3 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