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PLP — High Intensity Ultrasound System For Prostate Tissue Ablation Class II

FDA Device Classification

Classification Details

Product Code
PLP
Device Class
Class II
Regulation Number
876.4340
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

Prostate tissue ablation

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K251910edap technomedFocal One®November 19, 2025
K240296profound medicalTulsa Pro System (Pad-105)May 9, 2024
K231378insightecExablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100VOctober 30, 2023
K230692profound medicalTULSA-PRO SystemSeptember 20, 2023
K211858profound medicalTULSA-PRO SystemSeptember 6, 2022
K212150insightecExablate Prostate SystemNovember 23, 2021
K202286profound medicalTulsa-Pro SystemSeptember 16, 2020
K191200profound medicalTULSA-PRO SystemAugust 15, 2019
K172721edap technomedFOCAL ONEJune 7, 2018
K172285edap technomedAblatherm FusionOctober 3, 2017
K160942sonacare medicalSonablateDecember 21, 2016
K153023edap technomedAblatherm Integrated ImagingNovember 6, 2015
DEN150011sonacare medicalSonablate 450October 9, 2015