Pollogen, Ltd.

FDA Regulatory Profile

Summary

Total Recalls
0
510(k) Clearances
18
Inspections
0
Compliance Actions
0

Recent 510(k) Clearances

K-NumberDeviceDate
K242227GENEO X ELITEOctober 12, 2025
K252576Legend X PlatformSeptember 12, 2025
K250734OptiLUV DeviceSeptember 10, 2025
K243217Legend X Desktop SystemNovember 1, 2024
K240999Legend X Applicator VOMay 8, 2024
K233766Geneo X EliteMay 7, 2024
K232903Legend X PlatformOctober 17, 2023
K220322Pollogen STOP U Model UXV DeviceMay 4, 2023
K220124YandR System, VoluDerm Handpiece, VoluDerm TipsFebruary 17, 2022
K200545Legend Pro DMAOctober 21, 2021
K203665STOP U Model UXV DeviceFebruary 25, 2021
K182774STOP U (Packed Black USA), STOP U (Packed White USA)June 19, 2019
K173503Pollogen Legend SystemJune 11, 2018
K171359Pollogen Legend+ SystemSeptember 13, 2017
K140255STOP U (PACKED BLACK USA); STOP U (PACKED WHITE USA)May 14, 2014
K131758SURGEN UDecember 18, 2013
K122200A3F FRATIONALApril 18, 2013
K111026APOLLONovember 16, 2011