FDA Registration
Active
🇮🇱 Israel
Light based over the counter wrinkle reduction
Reg #: 3027645761
·
FEI: 3027645761
·
Expires 2025
Products
3
Proprietary Names
6
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- SILK'N BEAUTY LTD.
- Registration Number
- 3027645761
- FEI Number
- 3027645761
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Alon Ha-Tavor 15
- City
- Caesarea Central
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K171433
Owner / Operator
- Firm Name
- Silk'n Beauty Ltd.
- Operator Number
- 10087179
- Address
- Alon Ha-Tavor 15
- City
- Caesarea
- State
- Central
- Postal Code
- 3079516
- Country
- IL
- Correspondent
- Ahava Stein
US Agent
- Business Name
- A. Stein Regulatory Affairs Consulting Company Ltd.
- Contact Name
- Naphtali Deutsch
- Address
- 9559 COLLINS AVE, APARTMENT 1007
- City
- Surfside
- State
- FL
- ZIP
- 33154
- Country
- US
- [email protected]
- Phone
- 888 4433867
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | Class 2 | Neurology | No | 2023-07-12 |
| Light Based Over-The-Counter Hair Removal | OHT | Class 2 | General, Plastic Surgery | No | 2023-07-12 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | Class 2 | General, Plastic Surgery | No | 2023-07-12 |
Proprietary Names
Light based over the counter wrinkle reduction
Silk'n Infinity
Stimulator, transcutaneous electrical, aesthetic purposes
Silk'n Infinity Fast
Silk'n 7
Powered light based non-laser surgical instrument with thermal effect
Establishment Types
Manufacture Medical Device