FDA Registration
Active
🇨🇳 China
Dental Diode Laser System
Reg #: 3005581016
·
FEI: 3005581016
·
Expires 2025
Products
3
Proprietary Names
3
Establishment Types
1
Classifications
3
Registration Details
- Registration Name
- GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
- Registration Number
- 3005581016
- FEI Number
- 3005581016
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- Information Industrial Park, Guilin National High-Tech Zone
- City
- GUILIN CITY Guangxi
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K210367
Owner / Operator
- Firm Name
- GUILIN WOODPECKER MEDICAL INSTRUMENT CO., LTD
- Operator Number
- 9080879
- Address
- Information Industrial Park, Guilin National High-Tech Zone
- City
- GUILIN
- State
- Guangxi
- Postal Code
- 541004
- Country
- CN
US Agent
- Business Name
- IRC USA
- Contact Name
- CHARLES MACK
- Address
- 2950 E Lindrick Dr.
- City
- Chandler
- State
- AZ
- ZIP
- 85249
- Country
- US
- [email protected]
- Phone
- 931 6254938
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | Class 2 | Physical Medicine | No | 2022-03-18 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2022-03-18 |
| Laser, Dental, Soft Tissue | NVK | Class 2 | General, Plastic Surgery | No | 2022-03-18 |
Proprietary Names
Dental Diode Laser System
D-Laser 16, D-Laser Blue, LX 16, LX16 Plus
Laser Smart, Laser Smart Blue
Establishment Types
Manufacture Medical Device