Data / Medical devices / Israel / Pollogen Ltd

Pollogen Ltd: FDA-registered device maker in Tel Aviv, Israel, 13 510(k) clearances

Name: Pollogen Ltd FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Pollogen Ltd is registered with the FDA (registration 3008753275) in Tel Aviv, Israel. It lists 6 device types. The FDA files 13 510(k) clearances under its listings, the newest dated October 12, 2025. Registered through 2027. FDA data exported November 2, 2026.

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FDA registration number: 3008753275
Address: 6 Kaufman Street (main), Tel Aviv, Israel, 6801298
Owner or operator: Pollogen (10038980)
Roles: Manufacturer
First device listed: November 5, 2013
Registered through: 2027
Brand names listed: AURA Model VXU-301, Divine Pro, Divine Pro Model U, GEN 100, GEN 12, GEN 36, GEN 36L, GEN 36L DISPOSABLE TIP ASSY 5 PACK BK and more

Devices it lists

Device	Product code	Class	Role	Source
Brush, Dermabrasion, Powered	GFE	1	Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Manufacturer	accessdata.fda.gov
Massager, Therapeutic, Electric	ISA	1	Manufacturer	accessdata.fda.gov
Massager, Vacuum, Radio Frequency Induced Heat	PBX	2	Manufacturer	accessdata.fda.gov
Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction	PAY	2	Manufacturer	accessdata.fda.gov
Stimulator, Muscle, Powered, For Muscle Conditioning	NGX	2	Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
October 12, 2025	K242227	GENEO X ELITE	PAY	Substantially Equivalent	Pollogen, Ltd.	accessdata.fda.gov
September 12, 2025	K252576	Legend X Platform	GEI	Substantially Equivalent	Pollogen, Ltd.	accessdata.fda.gov
September 10, 2025	K250734	OptiLUV Device	PBX	Substantially Equivalent	Pollogen, Ltd.	accessdata.fda.gov
November 1, 2024	K243217	Legend X Desktop System	GEI	Substantially Equivalent	Pollogen, Ltd.	accessdata.fda.gov
May 8, 2024	K240999	Legend X Applicator VO	GEI	Substantially Equivalent	Pollogen, Ltd.	accessdata.fda.gov
May 7, 2024	K233766	Geneo X Elite	PAY	Substantially Equivalent	Pollogen, Ltd.	accessdata.fda.gov
October 17, 2023	K232903	Legend X Platform	GEI	Substantially Equivalent	Pollogen, Ltd.	accessdata.fda.gov
May 4, 2023	K220322	Pollogen STOP U Model UXV Device	PAY	Substantially Equivalent	Pollogen, Ltd.	accessdata.fda.gov
October 21, 2021	K200545	Legend Pro DMA	NGX	Substantially Equivalent	Pollogen, Ltd.	accessdata.fda.gov
February 25, 2021	K203665	STOP U Model UXV Device	PAY	Substantially Equivalent	Pollogen, Ltd.	accessdata.fda.gov
June 19, 2019	K182774	STOP U (Packed Black USA), STOP U (Packed White USA)	PAY	Substantially Equivalent	Pollogen, Ltd.	accessdata.fda.gov
June 11, 2018	K173503	Pollogen Legend System	GEI	Substantially Equivalent	Pollogen, Ltd.	accessdata.fda.gov
September 13, 2017	K171359	Pollogen Legend+ System	GEI	Substantially Equivalent	Pollogen, Ltd.	accessdata.fda.gov

Compare with other makers

Updated October 12, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.