POLLOGEN LTD

Address:6 Kaufman Street (main),Tel Aviv,IL

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- Catalog Number : 30009000U

Device Description : The Pollogen Legend+ system is intended for dermatological procedures requiring 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.

Device Class : 2

Duns Number: 514905681

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 20900270

Device Description : Applicators 1-3 provide RF energy that heats biological tissue in a controlled f 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.

Device Class : 2

Duns Number: 514905681

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 21400270

Device Description : Applicators 1-3 provide RF energy that heats biological tissue in a controlled f 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.2 is indicated for the treatment of medium size facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, also consisting of a plastic body with integrated electronic system, 3 electrodes and indication light guide ring.

Device Class : 2

Duns Number: 514905681

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 21400370

Device Description : Applicators 1-3 provide RF energy that heats biological tissue in a controlled f 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.3 is indicated for the treatment of very small facial areas. It is connected to the main unit by a cable containing electrical wiring and a connector, also consisting of a plastic body with integrated electronic system, 3 electrodes and indication light guide ring.

Device Class : 2

Duns Number: 514905681

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 21400800U

Device Description : The Pollogen Legend+ VO hand piece is designed to deliver radiofrequency energy The Pollogen Legend+ VO hand piece is designed to deliver radiofrequency energy to the skin in a non-homogeneous fractional manner, via an array of multi-electrode pins. The array delivers bipolar RF energy to the skin, resulting in heating of skin directly below the electrodes, to temperatures leading to ablation and resurfacing of the skin.

Device Class : 2

Duns Number: 514905681

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

Device Class :

Duns Number: 514905681

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

Device Class :

Duns Number: 514905681

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

Device Description : H7X7 DISPOSABLE TIP ASSY 5 PACKED

Device Class :

Duns Number: 514905681

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 5

- Catalog Number : 30020000U

Device Description : LEGEND PRO PACKEDApplicators 1-3 provide RF energy that heats biological tissue 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.

Device Class : 2

Duns Number: 514905681

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1

- Catalog Number : 20900300

Device Description : LP APPLICATOR 1Applicators 1-3 provide RF energy that heats biological tissue in 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.

Device Class : 2

Duns Number: 514905681

Premarket Exempt : No

Product Code : GEI

Prescription Use : Yes

Device Count : 1