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

Cleared Oct 12, 2025

GENEO X ELITE

K242227 · PAY

General & Plastic Surgery · 439d

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 Feb 25, 2021

STOP U Model UXV Device

K203665 · PAY

General & Plastic Surgery · 71d

Cleared CT 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