ClearanceBrief
Company ยท IL

Pollogen, Ltd.

FDA 510(k) clearances and medical device recalls filed under this name, 2011 to 2025. Name variants (Inc, Corp, punctuation) are merged.

18510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)

Product codes

CodeDeviceRecords
GEIElectrosurgical, Cutting & Coagulation & Accessories11
PAYOver-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction5
NGXStimulator, Muscle, Powered, For Muscle Conditioning1
PBXMassager, Vacuum, Radio Frequency Induced Heat1

Latest 510(k) clearances

Decided510(k)Device and applicantCode
Oct 12, 2025K242227GENEO X ELITE
Pollogen, Ltd., IL
PAY
Sep 12, 2025K252576Legend X Platform
Pollogen, Ltd., IL
GEI
Sep 10, 2025K250734OptiLUV Device
Pollogen, Ltd., IL
PBX
Nov 1, 2024K243217Legend X Desktop System
Pollogen, Ltd., IL
GEI
May 8, 2024K240999Legend X Applicator VO
Pollogen, Ltd., IL
GEI
May 7, 2024K233766Geneo X Elite
Pollogen, Ltd., IL
PAY
Oct 17, 2023K232903Legend X Platform
Pollogen, Ltd., IL
GEI
May 4, 2023K220322Pollogen STOP U Model UXV Device
Pollogen, Ltd., IL
PAY
Feb 17, 2022K220124YandR System, VoluDerm Handpiece, VoluDerm Tips
Pollogen, Ltd., IL
GEI
Oct 21, 2021K200545Legend Pro DMA
Pollogen, Ltd., IL
NGX
Feb 25, 2021K203665STOP U Model UXV Device
Pollogen, Ltd., IL
PAY
Jun 19, 2019K182774STOP U (Packed Black USA), STOP U (Packed White USA)
Pollogen, Ltd., IL
PAY
Jun 11, 2018K173503Pollogen Legend System
Pollogen, Ltd., IL
GEI
Sep 13, 2017K171359Pollogen Legend+ System
Pollogen, Ltd., IL
GEI
May 14, 2014K140255STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA)
Pollogen, Ltd.
GEI
Dec 18, 2013K131758SURGEN U
Pollogen, Ltd.
GEI
Apr 18, 2013K122200A3F FRATIONAL
Pollogen, Ltd., IL
GEI
Nov 16, 2011K111026APOLLO
Pollogen, Ltd., IL
GEI

Latest recalls

DateFirm and productCodeLinked 510(k)
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