FDA Registration
Active
🇨🇳 China
LUSTRE ClearSkin REVIVE Mask
Reg #: 3011644607
·
FEI: 3011644607
·
Expires 2025
Products
3
Proprietary Names
16
Establishment Types
2
Classifications
3
Registration Details
- Registration Name
- Shenzhen Kaiyan Medical Equipment Co., Ltd
- Registration Number
- 3011644607
- FEI Number
- 3011644607
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building#3 and Building#5, 40th of Fuxin Street, Huaide Community Fuyong Town, BaoAn District
- City
- Shenzhen Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K202390
Owner / Operator
- Firm Name
- Shenzhen Kaiyan Medical Equipment Co., Ltd
- Operator Number
- 10049428
- Address
- Building#3 and Building#5, 40th of Fuxin Street, Huaide Community, Fuyong Town ,, Bao'An District
- City
- Shenzhen
- State
- Guangdong
- Postal Code
- 518103
- Country
- CN
- Correspondent
- Alain Dijkstra
US Agent
- Business Name
- Light Tree Ventures USA LLC
- Contact Name
- Kim Markwat
- Address
- 6240 NE 4TH CT
- City
- Miami
- State
- FL
- ZIP
- 33138
- Country
- US
- [email protected]
- Phone
- 786 6471640
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2021-07-21 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2021-07-21 |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2021-07-21 |
Proprietary Names
LUSTRE ClearSkin REVIVE Mask
Aduro Facial Mask
Hammacher Schlemmer Anti-Aging LED Facial Rejuvenating Mask (Model #98670)
Clarifying Led Mask
Angela Caglia Crystal LED Face Mask
Mask & Glo Pro LED Mask
Bestqool LED Mask
KALA RED LIGHT FACE MASK
Peachaboo Silicone LED Light Therapy Mask
Luxeclinical Equinox LED Mask
Equinox LED Mask
Skillyes LED LIGHT THERAPY Facial Mask
Lumi Boosted Relaxation Eye Mask
RIKI loves RIKI baby face mask
Lifepro LED mask(Mode:LP-VZCR-BLK)
Angel Kiss Light Beauty Mask
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device