# K172721: Focal One

- Pathway: 510(k) (Traditional)
- Applicant: Edap Technomed, Inc.
- Decided: Jun 7, 2018 after 272 days
- Product code: PLP (High Intensity Ultrasound System For Prostate Tissue Ablation)
- Device class: 2
- Regulation: 21 CFR 876.4340
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to DEN150011 (2015). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K153023: Ablatherm Integrated Imaging, Edap Technomed, Inc. (2015) Summary page 4.
- K160942: Sonablate, Sonacare Medical, LLC (2016) Summary page 4.

## Most influential descendants
- K251910: Focal One® (2025), 0 descendants of its own

## Indications for use
The Focal One device is indicated for transrectal high intensity focused ultrasound (HIFU) ablation of prostate tissue.

Source page: https://510kreport.com/device/K172721
Methodology: https://510kreport.com/methodology