FDA Registration
Active
🇨🇳 China
Over-The-Counter Powered Light Based Laser For Acne-LED Light Therapy Mask(FM-01,FM-02,FM-03)
Reg #: 3013178978
·
FEI: 3013178978
·
Expires 2025
Products
3
Proprietary Names
1
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- Guangdong Newdermo Biotech Co., Ltd
- Registration Number
- 3013178978
- FEI Number
- 3013178978
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Building 70(C28),No.9 Huateng Road,Jinshan Village,Shiqi Town, Panyu District
- City
- Guangzhou Guangdong
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K223544
Owner / Operator
- Firm Name
- Guangdong Newdermo Biotech Co., Ltd
- Operator Number
- 10053680
- Address
- Building 70 (C28), No.9 Huateng Road, Jinshan Village, Shiqi Town, Panyu District
- City
- Guangzhou
- State
- Guangdong
- Postal Code
- 511450
- Country
- CN
- Correspondent
- Aimin Yang
US Agent
- Business Name
- MEDRIGHT TECH INC
- Contact Name
- Jessie Yao
- Address
- 6302 FORT HAMILTON PARKWAY, 1R
- City
- Brooklyn
- State
- NY
- ZIP
- 11219
- Country
- US
- [email protected]
- Phone
- 718 2169957
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 | 2023-03-19 |
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2023-03-19 |
| Light Based Over The Counter Wrinkle Reduction | OHS | Class 2 | General, Plastic Surgery | No | 2023-03-19 |
Proprietary Names
Over-The-Counter Powered Light Based Laser For Acne-LED Light Therapy Mask(FM-01,FM-02,FM-03)
Establishment Types
Manufacture Medical Device