Identity
- Trade Name
- Sonablate FDA UDI
- Generic Name
- Ultrasonic hyperthermia system FDA UDI
- Device Name
- Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy. FDA UDI
- Model / Reference
- 202-17000-0012 FDA UDI
- Description
- Sonablate Probe HF 30/40 3G is an image-guided device that allows physicians to ablate tissue using ultrasound energy. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868108000229 FDA UDI
- FDA Product Code
- PLP FDA UDI
- GMDN Term
- Ultrasonic hyperthermia system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 876.4340 FDA UDI
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
FDA UDI
Single Use
No
FDA UDI
Implantable
No
FDA UDI
Contains Latex
No
FDA UDI
Prescription Use
Yes
FDA UDI
Over-the-Counter
No
FDA UDI
Convenience Kit
No
FDA UDI
Combination Product
No
FDA UDI
HCT/P
No
FDA UDI
Premarket Exempt
No
FDA UDI
Lot / Batch Number
No
FDA UDI
Serial Number
Yes
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultrasonic hyperthermia system
Sonablate by Focus Surgery, Inc. — Class II — MDD, FDA UDI — listed in FDA GUDID, EUDAMED — regulatory data on deviCERTS
Similar devices
Also classified as Ultrasonic hyperthermia system.
- Quantel Er 7X7 Pixel — ALMA LASERS LTD. · Class II
- Accent Elite Unilarge HP — ALMA LASERS LTD. · Class II
- MYDON Nd:YAG Laser System — ALMA LASERS LTD. · Class II
- iPixel Module - Line Scan With Wheel and Support — ALMA LASERS LTD. · Class II
- 7290019402558 — Insightec · Class III
- Accent Elite II Pixel RF HP 110V (Alma Inc) — ALMA LASERS LTD. · Class II
- ARION Alexandrite Laser System — ALMA LASERS LTD. · Class II
- Spa RF HD3D Dielectric System 120V (white) — ALMA LASERS LTD. · Class II
Authorization Coverage (2 countries)
Regulatory Authorizations
European Union Unknown
MDD
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Unknown |
| FDA UDI | United States | FDA UDI | Registered in GUDID | Class II | Pending data |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Focus Surgery, Inc.
Sources (2)
- FDA UDI 028284e2-f7fc-49e7-8375-857cec7c94e6 33 fields · synced Jun 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026