FDA UDI
In Commercial Distribution
🇺🇸 United States
Liposonix
DI: 00816995020141
·
Model: P006392-03
·
SOLTA MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
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Basic Information
- Brand Name
- Liposonix
- Primary DI
- 00816995020141
- Version / Model
- P006392-03
- Catalog Number
- P006392-03
- Company Name
- SOLTA MEDICAL
- Labeler DUNS
- 079999584
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2016-09-23
- Public Version
- 5
- Public Version Date
- 2025-06-30
- Public Version Status
- Update
- Public Device Record Key
- 6799a0b0-9c3c-49ac-b7f0-93fc27bf086b
Device Description
INSTALLATION KIT, MODEL 2, GENERIC, P2.1
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- Yes
- Over the Counter (OTC)
- No
- Kit
- No
- Combination Product
- No
- HCT/P
- No
- Contains NRL
- No
- Not Made with NRL
- No
- MRI Safety
- Labeling does not contain MRI Safety Information
- Direct Marking Exempt
- No
- PM Exempt
- No
- Has Serial Number
- No
- Has Lot/Batch Number
- Yes
- Has Manufacturing Date
- Yes
- Has Expiration Date
- No
- Has Donation ID
- No
Sterilization
- Is Sterile
- No
- Sterilization Prior Use
- No
Product Codes
| Code | Name | Medical Specialty | Regulation # | Device Class |
|---|---|---|---|---|
| OHV | Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption | General, Plastic Surgery | 878.4590 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 45591 | Ultrasonic skin/body contouring system | An assembly of devices intended for the transdermal application of ultrasonic energy [e.g., high intensity focused ultrasound (HIFU)] to rupture subcutaneous fat cells to minimize the manifestation of cellulite, and/or to stimulate elastin/collagen production and tissue rejuvenation to improve the appearance of loose or wrinkled skin, and/or facial lines, for cosmetic purposes. The assembly typically consists of an electrically-powered generator, user controls/interface, and an ultrasonic transducer/handpiece; it may include a video imaging system to assist transducer positioning during treatment. This device may serve as a noninvasive outpatient procedure alternative to liposuction. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 00816995020141 | GS1 |