Silk'n
Basic Information
- Brand Name
- Silk'n
- Primary DI
- 17290019840036
- Version / Model
- BellaVisage Hybrid
- Catalog Number
- 7290019840039
- Company Name
- SILKN BEAUTY LTD
- Labeler DUNS
- 625893101
- Distribution Status
- In Commercial Distribution
- Device Count in Pkg
- 1
- Record Status
- Published
- Publish Date
- 2023-08-15
- Public Version
- 2
- Public Version Date
- 2023-11-03
- Public Version Status
- Update
- Public Device Record Key
- be92487e-fcd3-479f-9fc4-bd8a112f4b64
Device Description
The BellaVisage Hybrid is an over-the-counter home use device intended for non-invasive treatment of mild to moderate periorbital wrinkles for adult women who have Fitzpatrick skin types I-IV. The Silk'n BellaVisage Hybrid is designed as a hand-held device, battery operated which utilizes both Bi-Polar RF and low power light energies. The device includes RF generator, LEDs at wavelengths of 630±20nm and 850±20nm (Red and IR wavelengths, respectively) and a temperature stabilizer. The device consists of an applicator and an adaptor. The applicator is a handheld unit used for treatment. The device has a treatment surface with 3 electrodes and a control button with 4 surrounding indicator lights. The device has a rechargeable battery for cordless use, as well as an adapter for connection to the mains.
Device Characteristics
- Single Use
- No
- Prescription Use (Rx)
- No
- Over the Counter (OTC)
- Yes
- 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 |
|---|---|---|---|---|
| PAY | Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | General, Plastic Surgery | 878.4420 | 2 |
| OHS | Light Based Over The Counter Wrinkle Reduction | General, Plastic Surgery | 878.4810 | 2 |
GMDN Terms
| Code | Name | Definition | Implantable | Status |
|---|---|---|---|---|
| 58455 | Radio-frequency skin surface treatment system applicator | A handpiece component of a radio-frequency skin surface treatment system designed to be used by a healthcare professional to deliver bipolar radio-frequency (RF) energy to the skin surface for skin resurfacing. It is typically designed to deliver RF energy to the skin in a non-homogenous fractional manner, via an array of multi-electrode pins, to leave minimal-impact areas of skin to facilitate healing. The applicator connects with the system’s control unit and may include vacuum to facilitate its coupling with the skin. This is a reusable device. | No | Active |
Identifiers
| Type | ID | Issuing Agency | Package Type | Qty per Pkg | Pkg Status | Pkg Discontinue Date |
|---|---|---|---|---|---|---|
| Direct Marking | 07290019840039 | GS1 | ||||
| Primary | 17290019840036 | GS1 |
Customer Contacts
- Phone
- 1-877-367-4556
- [email protected]
Premarket Submissions
| Submission Number | Supplement Number |
|---|---|
| K162784 | 000 |
Storage Conditions
- Type
- Handling Environment Temperature
- Temperature Range
- 10 – 35 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 30 – 75 Percent (%) Relative Humidity
- Type
- Storage Environment Temperature
- Temperature Range
- -40 – 70 Degrees Celsius
- Type
- Storage Environment Humidity
- Temperature Range
- 10 – 90 Percent (%) Relative Humidity
- Type
- Handling Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal
- Type
- Storage Environment Atmospheric Pressure
- Temperature Range
- 70 – 106 KiloPascal