Identity
- Trade Name
- Liposonix FDA UDI
- Generic Name
- Ultrasonic skin/body contouring system FDA UDI
- Device Name
- INSTALLATION KIT, MODEL 2, GENERIC, P2.1 FDA UDI
- Model / Reference
- P006392-03 FDA UDI
- Description
- INSTALLATION KIT, MODEL 2, GENERIC, P2.1 FDA UDI
Identifiers
- Catalog Number
- P006392-03 FDA UDI
- Primary DI / UDI-DI
- 00816995020141 FDA UDI
- FDA Product Code
- OHV FDA UDI
- GMDN Term
- Ultrasonic skin/body contouring system FDA UDI
Classification
- Device Class
- Class II FDA UDI
- Regulation Number
- 878.4590 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
Yes
FDA UDI
Serial Number
No
FDA UDI
Expiration Date
No
FDA UDI
Manufacturing Date
Yes
FDA UDI
Category: Ultrasonic skin/body contouring system
Liposonix by Solta Medical, Inc. — Class II — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS
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Also classified as Ultrasonic skin/body contouring system.
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- Ulthera System Handpiece — Ulthera Inc · Class II
- Ulthera System — Ulthera Inc · Class II
- Ulthera System Handpiece — Ulthera Inc · Class II
- Ulthera System Handpiece — Ulthera Inc · Class II
- Ulthera System Control Unit — Ulthera Inc · Class II
- Ulthera System Handpiece — Ulthera Inc · 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 |
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Manufacturer
- Manufacturer
- Solta Medical, Inc.
Sources (1)
- FDA UDI 6799a0b0-9c3c-49ac-b7f0-93fc27bf086b 34 fields · synced Jun 6, 2026