Identity
- Trade Name
- Sonasource FDA UDI
- Generic Name
- Ultrasonic hyperthermia system FDA UDI
- Device Name
- Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control SonaCare Medical's probes. The console includes all electronics required for user interaction with all probe imaging and treatment functions. FDA UDI
- Model / Reference
- 102-17000-0009 FDA UDI
- Description
- Sonasource is comprised of several integrated programmable hardware and software modules that are used to drive and control SonaCare Medical's probes. The console includes all electronics required for user interaction with all probe imaging and treatment functions. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 00868108000212 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
Sonasource by Focus Surgery, Inc. — Class II — FDA UDI — listed in FDA GUDID — 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 (1 country)
Regulatory Authorizations
United States Pending data
FDA UDI
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| 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 (1)
- FDA UDI 783dc90c-ebde-4407-b7f5-d261d38bfdf3 33 fields · synced Jun 8, 2026