Medical Device Manufacturer · IL , Binyamina

Pollogen, Ltd. - FDA 510(k) Cleared Devices

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

Pollogen, Ltd. has 18 FDA 510(k) cleared general & plastic surgery devices. Based in Binyamina, IL.

Latest FDA clearance: Oct 2025. Active since 2011.

Browse the complete list of FDA 510(k) cleared general & plastic surgery devices from this manufacturer. Filter by specialty or product code using the sidebar.

Regulatory submissions have been managed by BioVision , Ltd., Regulatory Technology Services, LLC and Benjamin L. England and Associates.

FDA 510(k) Regulatory Record - Pollogen, Ltd.
18 devices
1-18 of 18
Cleared Oct 12, 2025
GENEO X ELITE
K242227 · PAY
General & Plastic Surgery · 439d
Cleared Sep 12, 2025
Legend X Platform
K252576 · GEI
Neurology · 29d
Cleared Sep 10, 2025
OptiLUV Device
K250734 · PBX
General & Plastic Surgery · 183d
Cleared Nov 01, 2024
Legend X Desktop System
K243217 · GEI
General & Plastic Surgery · 29d
Cleared May 08, 2024
Legend X Applicator VO
K240999 · GEI
General & Plastic Surgery · 27d
Cleared May 07, 2024
Geneo X Elite
K233766 · PAY
General & Plastic Surgery · 165d
Cleared Oct 17, 2023
Legend X Platform
K232903 · GEI
General & Plastic Surgery · 29d
Cleared May 04, 2023
Pollogen STOP U Model UXV Device
K220322 · PAY
General & Plastic Surgery · 455d
Cleared Feb 17, 2022
YandR System, VoluDerm Handpiece, VoluDerm Tips
K220124 · GEI
General & Plastic Surgery · 30d
Cleared Oct 21, 2021
Legend Pro DMA
K200545 · NGX
Neurology · 597d
Cleared Feb 25, 2021
STOP U Model UXV Device
K203665 · PAY
General & Plastic Surgery · 71d
Cleared Jun 19, 2019
STOP U (Packed Black USA), STOP U (Packed White USA)
K182774 · PAY
General & Plastic Surgery · 261d
Cleared Jun 11, 2018
Pollogen Legend System
K173503 · GEI
General & Plastic Surgery · 210d
Cleared Sep 13, 2017
Pollogen Legend+ System
K171359 · GEI
General & Plastic Surgery · 127d
Cleared May 14, 2014
STOP U (PACKED BLACK USA)
K140255 · GEI
General & Plastic Surgery · 103d
Cleared Dec 18, 2013
SURGEN U
K131758 · GEI
General & Plastic Surgery · 184d
Cleared Apr 18, 2013
A3F FRATIONAL
K122200 · GEI
General & Plastic Surgery · 267d
Cleared Nov 16, 2011
APOLLO
K111026 · GEI
General & Plastic Surgery · 217d
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