Pollogen, Ltd. - FDA 510(k) Cleared Devices
18
Total
18
Cleared
0
Denied
FDA 510(k) cleared devices by Pollogen, Ltd. General & Plastic Surgery ✕
16 devices
Cleared
Oct 12, 2025
GENEO X ELITE
General & Plastic Surgery
439d
Cleared
Sep 10, 2025
OptiLUV Device
General & Plastic Surgery
183d
Cleared
Nov 01, 2024
Legend X Desktop System
General & Plastic Surgery
29d
Cleared
May 08, 2024
Legend X Applicator VO
General & Plastic Surgery
27d
Cleared
May 07, 2024
Geneo X Elite
General & Plastic Surgery
165d
Cleared
Oct 17, 2023
Legend X Platform
General & Plastic Surgery
29d
Cleared
May 04, 2023
Pollogen STOP U Model UXV Device
General & Plastic Surgery
455d
Cleared
Feb 17, 2022
YandR System, VoluDerm Handpiece, VoluDerm Tips
General & Plastic Surgery
30d
Cleared
Feb 25, 2021
STOP U Model UXV Device
General & Plastic Surgery
71d
Cleared
Jun 19, 2019
STOP U (Packed Black USA), STOP U (Packed White USA)
General & Plastic Surgery
261d
Cleared
Jun 11, 2018
Pollogen Legend System
General & Plastic Surgery
210d
Cleared
Sep 13, 2017
Pollogen Legend+ System
General & Plastic Surgery
127d
Cleared
May 14, 2014
STOP U (PACKED BLACK USA)
General & Plastic Surgery
103d
Cleared
Dec 18, 2013
SURGEN U
General & Plastic Surgery
184d
Cleared
Apr 18, 2013
A3F FRATIONAL
General & Plastic Surgery
267d
Cleared
Nov 16, 2011
APOLLO
General & Plastic Surgery
217d