Edap Technomed Inc.

FDA Device Registration & Listing · Austin, TX, US · Registration 1287394

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1287394
FEI Number
1287394
Entity Name
Edap Technomed Inc.
City/State/Country
Austin, TX, US
Establishment Address
5321 Industrial Oaks Blvd, Suite 110, Austin, TX 78735, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
EDAP Technomed Inc. (Owner Number: 10040253)
Owner / Operator Contact Address
5321 Industrial Oaks Blvd., Suite 110, Austin, TX 78735, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K172285
PMA Number
N/A

All Registered Proprietary Names

Focal One i Focal One Ablatherm Fusion

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PLP High Intensity Ultrasound System For Prostate Tissue Ablation Gastroenterology, Urology Class 2 876.4340 2025-12-10
PLP High Intensity Ultrasound System For Prostate Tissue Ablation Gastroenterology, Urology Class 2 876.4340 2018-06-07
PLP High Intensity Ultrasound System For Prostate Tissue Ablation Gastroenterology, Urology Class 2 876.4340 2018-11-02

Official Correspondent

Hugo Embert

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

EDAP Technomed Inc.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1287394. Last updated year: 2026. Please use registration number 1287394 when referencing this establishment in official correspondence.
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