# Edap Technomed, Inc.

- Location (FDA's records): Austin, TX
- FDA decisions: 5 (2001–2025): 5 510(k) clearances
- Product codes: PLP (4), LNS (1)
- Predicates its devices cite: 6 (3 its own); citations of its devices by later devices: 8 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Sonacare Medical, LLC: 3 (https://510kreport.com/company/sonacare-medical)

## Firms that cite its devices most
- Edap Tms France: 1 (https://510kreport.com/company/edap-tms-france)
- E.S.W.L. Products, Inc.: 1 (https://510kreport.com/company/eswl-products)
- Technomed Medical Systems, SA: 1 (https://510kreport.com/company/technomed-medical-systems)
- FMD Co., Ltd.: 1 (https://510kreport.com/company/fmd)
- Profound Medical, Inc.: 1 (https://510kreport.com/company/profound-medical)

## Its most-cited devices
- K003529: Sonolith Praktis, Endourology Table Praktis (2001), cited by 4
- K153023: Ablatherm Integrated Imaging (2015), cited by 3
- K172721: Focal One (2018), cited by 1

## Recent decisions
- K251910: Focal One® (Nov 19, 2025)
- K172721: Focal One (Jun 7, 2018)
- K172285: Ablatherm Fusion (Oct 3, 2017)
- K153023: Ablatherm Integrated Imaging (Nov 6, 2015)
- K003529: Sonolith Praktis, Endourology Table Praktis (Feb 12, 2001)

Source page: https://510kreport.com/company/edap-technomed