Medical Device Manufacturer · IL , Binyamina

Pollogen, Ltd.

18 submissions · 18 cleared · Since 2011
18
Total
18
Cleared
0
Denied

Pollogen, Ltd. — FDA 510(k) Submissions

Pollogen, Ltd. has submitted 18 FDA 510(k) premarket notifications since 2011, of which 18 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Electrosurgical, Cutting & Coagulation & Accessories, Over-the-counter Radiofrequency Coagulation Device For Wrinkle Reduction, Stimulator, Muscle, Powered, For Muscle Conditioning, Massager, Vacuum, Radio Frequency Induced Heat . Use the specialty filter in the sidebar to narrow results.

18 devices
1–18 of 18
GENEO X ELITE
K242227 · PAY Over-the-counter... · General & Plastic Surgery
Oct 2025 439d
Legend X Platform
K252576 · GEI Electrosurgical, Cutting... · Neurology
Sep 2025 29d
OptiLUV Device
K250734 · PBX Massager, Vacuum, Radio... · General & Plastic Surgery
Sep 2025 183d
Legend X Desktop System
K243217 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Nov 2024 29d
Legend X Applicator VO
K240999 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2024 27d
Geneo X Elite
K233766 · PAY Over-the-counter... · General & Plastic Surgery
May 2024 165d
Legend X Platform
K232903 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Oct 2023 29d
Pollogen STOP U Model UXV Device
K220322 · PAY Over-the-counter... · General & Plastic Surgery
May 2023 455d
YandR System, VoluDerm Handpiece, VoluDerm Tips
K220124 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Feb 2022 30d
Legend Pro DMA
K200545 · NGX Stimulator, Muscle,... · Neurology
Oct 2021 597d
STOP U Model UXV Device
K203665 · PAY Over-the-counter... · General & Plastic Surgery
Feb 2021 71d
STOP U (Packed Black USA), STOP U (Packed White USA)
K182774 · PAY Over-the-counter... · General & Plastic Surgery
Jun 2019 261d
Pollogen Legend System
K173503 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Jun 2018 210d
Pollogen Legend+ System
K171359 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Sep 2017 127d
STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA)
K140255 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
May 2014 103d
SURGEN U
K131758 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Dec 2013 184d
A3F FRATIONAL
K122200 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Apr 2013 267d
APOLLO
K111026 · GEI Electrosurgical, Cutting... · General & Plastic Surgery
Nov 2011 217d
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