FDA UDI
In Commercial Distribution
🇺🇸 United States
Liposonix
DI: 00816995020158
·
Model: P006530-04
·
SOLTA MEDICAL
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Liposonix
- Primary DI
- 00816995020158
- Version / Model
- P006530-04
- Catalog Number
- P006530-04
- 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
- 4
- Public Version Date
- 2018-11-05
- Public Version Status
- Update
- Public Device Record Key
- d2b5df2a-862a-4998-b009-c6d65a0accf4
Device Description
CARTRIDGE, REPLACEABLE TREATMENT
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
- Yes
- Has Lot/Batch Number
- No
- 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 body contouring system | An assembly of devices intended for the transdermal application of ultrasonic energy to rupture targeted fat cells in areas where they tend to enlarge (e.g., hips, thighs, abdomen, buttocks), to reshape those areas for cosmetic purposes. The assembly typically consists of a mains electricity (AC-powered) ultrasonic energy generator with user controls/interface and an ultrasonic transducer used to transmit the energy to a target area to emulsify fat cells; it may include a video imaging system that takes into account real-time body movement to precisely position the transducer during treatment. The use of this system 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 | 00816995020158 | GS1 |