FDA UDI
In Commercial Distribution
🇺🇸 United States
Sofwave Applicator
DI: 07290018152027
·
Model: FG00002-R
·
SOFWAVE MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sofwave Applicator
- Primary DI
- 07290018152027
- Version / Model
- FG00002-R
- Catalog Number
- FG00002-R
- Company Name
- SOFWAVE MEDICAL LTD
- Labeler DUNS
- 531962539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2021-05-27
- Public Version
- 1
- Public Version Date
- 2021-06-04
- Public Version Status
- New
- Public Device Record Key
- 315cc7f4-7021-4f4c-a85a-5a820dd8a2dd
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- 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
- No
- 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 |
|---|---|---|---|---|
| 62436 | Ultrasonic skin contouring system | A mobile assembly of electrically-powered devices intended to temporarily minimize the manifestation of cellulite, loose or wrinkled skin, and/or facial lines through the extracorporeal application of high-intensity/frequency ultrasound [e.g., high intensity focused ultrasound (HIFU)]. It is typically used on the head and neck where it generates low levels of heat in the targeted tissue to stimulate the cells for elastin/collagen production and tissue rejuvenation. It typically consists of a high-intensity/frequency generator/control unit, handpiece, transducer cartridge and connection cable. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Primary | 07290018152027 | GS1 |
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K191421 | 000 |