FDA UDI
In Commercial Distribution
🇺🇸 United States
Sofwave Applicator
DI: 07290018152089
·
Model: FG00004
·
SOFWAVE MEDICAL LTD
Product Codes
1
GMDN Terms
1
Identifiers
1
Pkg Device Count
1
Basic Information
- Brand Name
- Sofwave Applicator
- Primary DI
- 07290018152089
- Version / Model
- FG00004
- Catalog Number
- FG00004
- Company Name
- SOFWAVE MEDICAL LTD
- Labeler DUNS
- 531962539
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2025-02-16
- Public Version
- 1
- Public Version Date
- 2025-02-24
- Public Version Status
- New
- Public Device Record Key
- c93dd3e9-6efb-4ddc-ae6c-463705aa6f30
Device Description
The SofWave System is an ultrasound system intended for aesthetic purposes. The SofWave System consists of two main functional components: 1) the console and 2) the applicator. The applicator component of SofWave System exists in three forms to allow the user treatment flexibility, This applicator is the large (liftHD) applicator, designed to allow the user treatment flexibility and easier access to larger treatment areas.
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
- Yes
- 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 |
|---|---|---|---|---|
| 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 | 07290018152089 | GS1 |
Premarket Submissions
Storage Conditions
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 158 Degrees Fahrenheit
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 93 Percent (%) Relative Humidity