Home / 510(k) Clearances / K251910

510(k) K251910

Focal One® by Edap Technomed, Inc. — Product Code PLP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 19, 2025
Date Received
June 20, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
High Intensity Ultrasound System For Prostate Tissue Ablation
Device Class
Class II
Regulation Number
876.4340
Review Panel
GU
Submission Type

Prostate tissue ablation

Other clearances by Edap Technomed, Inc.

  • K172721 — FOCAL ONE (June 7, 2018)
  • K172285 — Ablatherm Fusion (October 3, 2017)
  • K153023 — Ablatherm Integrated Imaging (November 6, 2015)
  • K003529 — SONOLITH PRAKTIS, ENDOUROLOGY TABLE PRAKTIS (February 12, 2001)

Other clearances for product code PLP

  • K240296 — Tulsa Pro System (Pad-105) (May 9, 2024)
  • K231378 — Exablate Model 2100V1, Exablate Prostate System, Exablate MRgFUS, Exablate 2100V (October 30, 2023)
  • K230692 — TULSA-PRO System (September 20, 2023)
  • K211858 — TULSA-PRO System (September 6, 2022)
  • K212150 — Exablate Prostate System (November 23, 2021)
  • K202286 — Tulsa-Pro System (September 16, 2020)
  • K191200 — TULSA-PRO System (August 15, 2019)
  • K172721 — FOCAL ONE (June 7, 2018)
  • K172285 — Ablatherm Fusion (October 3, 2017)
  • K160942 — Sonablate (December 21, 2016)