FDA Registration
Active
🇳🇱 Netherlands
SILK'N BEAUTY LTD.
Reg #: 3027645761
·
FEI: 3027645761
·
Expires 2026
Products
13
Proprietary Names
33
Establishment Types
2
Classifications
13
Registration Details
- Registration Name
- SILK'N BEAUTY LTD.
- Registration Number
- 3027645761
- FEI Number
- 3027645761
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Galileistraat 17
- City
- Rotterdam Zuid-Holland
- Country
- NL
Regulatory Submissions
- 510(k) Number
- K121435
Owner / Operator
- Firm Name
- Silk'n Beauty Ltd.
- Operator Number
- 10087179
- Address
- Galileistraat 17, 3029 AL
- City
- Rotterdam
- State
- Zuid-Holland
- Postal Code
- 3029
- Country
- NL
- Correspondent
- Ahava Stein
US Agent
- Business Name
- A. Stein Regulatory Affairs Consulting Company Ltd.
- Contact Name
- Naphtali Deutsch
- Address
- 9595 Collins Ave Apt 506
- City
- Surfside
- State
- FL
- ZIP
- 33154
- Country
- US
- [email protected]
- Phone
- 888 4433867
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2023-07-12 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2023-07-12 |
| Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | PAY | Class 2 | General, Plastic Surgery | No | 2023-07-12 |
| Massager, Therapeutic, Electric | ISA | Class 1 | Physical Medicine | No | 2023-07-12 |
| Light Based Over-The-Counter Hair Removal | OHT | Class 2 | General, Plastic Surgery | No | 2023-07-12 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2023-07-12 |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | Class 2 | Neurology | No | 2023-07-12 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | Class 2 | General, Plastic Surgery | No | 2023-07-12 |
| Vibrator For Therapeutic Use, Genital | KXQ | Class 2 | Obstetrics/Gynecology | No | 2023-07-12 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2023-11-21 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2023-07-12 |
| Powered Radiofrequency Toothbrush | QMJ | Class 2 | Dental | No | 2023-07-12 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-07-12 |
Proprietary Names
Over-the-counter powered light based laser for acne
Light based over the counter wrinkle reduction
Over-the-counter radiofrequency coagulation device for wrinkle reduction
Massager, therapeutic, electric
Light based over-the-counter hair removal
Brush, dermabrasion, powered
Stimulator, transcutaneous electrical, aesthetic purposes
Silk'n 7
Silk'n Infinity Fast
Powered light based non-laser surgical instrument with thermal effect
Silk'n Infinity
Vibrator for therapeutic use genital
Flash & Go Pro
Light based over the counter hair removal
Motion Premium
BellaFlash Pro
LED light therapy mask
Silk'n LED Face Mask 100
Silk'n LED Neck Mask
Stimulator, muscle, powered, for muscle conditioning
Titan Mini
FaceTite (Titan) Mini
FaceTite (Titan) MultiPlatform
Titan MultiPlatform
Silk'n Titan Allways
FaceTite MultiPlatform
FaceTite Mini
powered radiofrequency toothbrush
Electrosurgical, cutting & coagulation & accessories
Lamp, infrared, therapeutic heating
LumiLips FAC07NA
LED Light Therapy Mask
LumiLips
Establishment Types
Manufacture Medical Device
Repack or Relabel Medical Device