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510(k) K251910

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

K251910 is an FDA 510(k) premarket notification submitted by Edap Technomed, Inc. for the device "Focal One®". The FDA issued a decision of Substantially Equivalent on November 19, 2025. The device falls under product code PLP (High Intensity Ultrasound System For Prostate Tissue Ablation), a Class II device regulated under 21 CFR 876.4340. Edap Technomed, Inc. has at least 4 other 510(k) clearances on record.

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)

FDA data resources