FDA Product Code PLP: High Intensity Ultrasound System For Prostate Tissue Ablation
Prostate Tissue Ablation
Leading manufacturers include Profound Medical, Inc., Edap Technomed, Inc. and InSightec, Inc..
13
Total
12
Cleared
166d
Avg days
2015
Since
Declining activity -
1 submissions in the last 2 years
vs 4 in the prior period
Consistent review times:
152d avg (recent)
FDA 510(k) Cleared High Intensity Ultrasound System For Prostate Tissue Ablation Devices (Product Code PLP)
13 devices
Cleared
Nov 19, 2025
Focal One®
Edap Technomed, Inc.
Gastroenterology & Urology
152d
Cleared
May 09, 2024
Tulsa Pro System (Pad-105)
Profound Medical, Inc.
Gastroenterology & Urology
98d
Cleared
Oct 30, 2023
Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V1 Type 3.0
Insightec , Ltd.
Gastroenterology & Urology
171d
Cleared
Sep 20, 2023
TULSA-PRO System
Profound Medical, Inc.
Gastroenterology & Urology
191d
Cleared
Sep 06, 2022
TULSA-PRO System
Profound Medical, Inc.
Gastroenterology & Urology
447d
Cleared
Nov 23, 2021
Exablate Prostate System
InSightec, Inc.
Gastroenterology & Urology
137d
Cleared
Sep 16, 2020
Tulsa-Pro System
Profound Medical, Inc.
Gastroenterology & Urology
35d
Cleared
Aug 15, 2019
TULSA-PRO System
Profound Medical, Inc.
Gastroenterology & Urology
101d
Cleared
Jun 07, 2018
FOCAL ONE
Edap Technomed, Inc.
Gastroenterology & Urology
272d
About Product Code PLP - Regulatory Context
510(k) Submission Activity
13 total 510(k) submissions under product code PLP since 2015, with 12 receiving FDA clearance (average review time: 166 days).
Submission volume has declined in recent years - 1 submissions in the last 24 months compared to 4 in the prior period.
FDA 510(k) Review Time - PLP Product Code
FDA review times for PLP submissions have been consistent, averaging 152 days recently vs 167 days historically.
PLP devices are reviewed by the Gastroenterology & Urology panel. Browse all Gastroenterology & Urology devices →