FDA Registration
Active
🇨🇳 China
Solawave Bye Acne
Reg #: 3011644607
·
FEI: 3011644607
·
Expires 2025
Products
3
Proprietary Names
10
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
- K203271
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 |
|---|---|---|---|---|---|
| Over-The-Counter Powered Light Based Laser For Acne | OLP | Class 2 | General, Plastic Surgery | No | 2021-07-26 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2021-07-26 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2021-07-26 |
Proprietary Names
Solawave Bye Acne
Aduro Plam
KALA THERAPY WAND
Solawave Bye Acne 3 Minute Light Therapy
LED Esthetics Acne Pen
caring mill Anti-Acne Light Therapy Device
RIKI LOVES RIKI RIKI Miracle acne patch
CurrentBody Skin Anti-Blemish LED Pen
Groomie Hers GlowUp Acne Wand
CurrentBody Skin Anti-Acne LED Pen
Establishment Types
Export Device to the United States But Perform No Other Operation on Device
Manufacture Medical Device