Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3008753275

FEI Number

3008753275

Entity Name

POLLOGEN LTD

City/State/Country

Tel Aviv, IL

Establishment Address

6 Kaufman Street (main), Tel Aviv 6801298, IL

Establishment Type(s)

Manufacture Medical Device

Owner / Operator

Pollogen (Owner Number: 10038980)

Owner / Operator Contact Address

6 Kaufman Str., Tel Aviv, IL-TA 6801298, IL

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K232903

PMA Number

N/A

All Registered Proprietary Names

triLift GENEO X U PACKED GENEO+ U PACKED GENEO X U system including Oxygeneo Applicator GENEO X U system including Oxfoliation Applicator GENEO+ U system including Oxygeneo Applicator geneO+ U RF PRO Handpiece for GENEO X GENEO X U with TRIPOLLAR RF APPLICATOR KIT for GENEO X U GENEO X ELITE System with TriPollar RF and Oxygeneo Applicators GENEO X U PACKED with GENEO X TRIPOLLAR KIT USA PACKED Glo2Facial by Geneo RF PRO Handpiece Kit for GENEO X AURA Model VXU-301 STOP VX MODEL U STOP U MODEL UXV STOP VX2 MODEL U MyLift Model VXU-302 Legend X Applicator VO Glo2Facial By Geneo RF PRO Handpiece Kit for GENEO X GENEO X U with TriPollar RF PRO APPLICATOR KIT for GENEO X U RF PRO Handpiece for GENEO X GENEO X U PACKED with GENEO X TRIPOLLAR KIT USA PACKED GENEO X ELITE System with TriPollar RF and Oxygeneo Applicators Legend Pro Pollogen Legend+ System LP GEN 100 DISPOSABLE TIP ASSY LP H7X7 DISPOSABLE TIP ASSY 5 PACKED LP GEN 36 DISPOSABLE TIP ASSY 5 PACKED LP H7X7 DISPOSABLE TIP ASSY LP GEN 36L DISPOSABLE TIP ASSY 5 PACKED LP GEN 12 DISPOSABLE TIP ASSY LP GEN 36 DISPOSABLE TIP ASSY GEN 36L LP GEN 100 DISPOSABLE TIP ASSY 5 PACKED GEN 36L DISPOSABLE TIP ASSY 5 PACK BK LP GEN 12 DISPOSABLE TIP ASSY 5 PACKED GEN 100 GEN 12 GEN100 DISPOSABLE TIP ASSY 5 PACK BK H7X7 Legend Pro Gen 100 tips GEN12 DISPOSABLE TIP ASSY 5 PACK BK GEN 36 triFX 100 TIP ASSY 5 PACK LP GEN 36L DISPOSABLE TIP ASSY GEN36 DISPOSABLE TIP ASSY 5 PACK BK TriLift H7X7 DISPOSABLE TIP ASSY 5 PACK BK triFX H7X7 TIP ASSY 5 PACK triFX 36 TIP ASSY 5 PACK triFX 36L TIP ASSY 5 PACK triFX 12 TIP ASSY 5 PACK triLift Legend X

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-12-01
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2025-12-01
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2014-11-05
GFE	Brush, Dermabrasion, Powered	General, Plastic Surgery	Class 1	878.4820	2013-11-05
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4420	2024-07-18
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2024-07-18
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4420	2023-12-24
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2025-01-23
ISA	Massager, Therapeutic, Electric	Physical Medicine	Class 1	890.5660	2026-03-26
PAY	Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	General, Plastic Surgery	Class 2	878.4420	2026-03-26
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2018-08-28
GEI	Electrosurgical, Cutting & Coagulation & Accessories	General, Plastic Surgery	Class 2	878.4400	2024-02-06
NGX	Stimulator, Muscle, Powered, For Muscle Conditioning	Physical Medicine	Class 2	890.5850	2024-02-06

Official Correspondent

Kai Hanover

US Agent Details

Tova Rivnay Business: Qsite Email: tova@qsitemed.com Phone: (512) 5354930

Related Public Records

Same Entity

Pollogen

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K970809	Somnus Medical Technologies, Inc.	BENDABLE TISSUE COAGULATING ELECTRODE WITH BENDING TOOL	1997-06-18
K222793	C.R. Bard, Inc.	WavelinQ Generator	2022-10-17
K002257	Tecno Instruments (Pvt.) , Ltd.	TECNO DISPOSABLE FINGERSWITCH PENCIL, MODEL 150-100	2000-10-19
K193591	Bowa-Electronics GmbH & Co. KG	ARC 400	2020-04-02
K192128	Sutter Medizintechnik GmbH	Sutter Arrowtip Monopolar Electrodes	2019-10-04

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0031-06	Rita Medical Systems	2	Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

Similar Registrations

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3012616488	BRERA MEDICAL INCORPORATED	Northborough, MA, US
3012940012	Sutter Medical Technologies USA Inc.	Alpharetta, GA, US

Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3008753275. Last updated year: 2026. Please use registration number 3008753275 when referencing this establishment in official correspondence.