FDA Registration
Active
🇨🇳 China
Smart Laser Therapy Machines
Reg #: 3026038437
·
FEI: 3026038437
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
2
Classifications
1
Registration Details
- Registration Name
- RHEIN LASER TECHNOLOGIES CO., LTD.
- Registration Number
- 3026038437
- FEI Number
- 3026038437
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 6F, B2-A Building, No.999 High-Tech Avenue, Future City, East Lake High-Tech Development Zone
- City
- wuhan Hubei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K222862
Owner / Operator
- Firm Name
- Rhein Laser Technologies Co., Ltd.
- Operator Number
- 10087178
- Address
- 801,8F, E2 Building,Future City, No.999 High-Tech Avenue, East Lake High-Tech Development Zone, Wuhan 430206,China( Free Trade Zone Wuhan Area)
- City
- wuhan
- State
- Hubei
- Postal Code
- 430206
- Country
- CN
- Correspondent
- Shelly Mao
US Agent
- Business Name
- BraunSolutions Regulatory Group
- Contact Name
- Alexander Henderson
- Address
- 2298 Americus Blvd East, Unit 14
- City
- Clearwater
- State
- FL
- ZIP
- 33763
- Country
- US
- [email protected]
- Phone
- 720 5894939
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2023-09-21 |
Proprietary Names
Smart Laser Therapy Machines
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device