FDA Registration
Active
🇨🇳 China
HEBEI KEYLASER SCI-TECH CO., LTD.
Reg #: 3037047060
·
FEI: 3037047060
·
Expires 2026
Products
1
Proprietary Names
10
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- HEBEI KEYLASER SCI-TECH CO., LTD.
- Registration Number
- 3037047060
- FEI Number
- 3037047060
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 4th Floor Building C18-2, HeGu Industry Park, Chaoyang East Road, ZhuoZhou
- City
- Baoding Hebei
- Country
- CN
Regulatory Submissions
- 510(k) Number
- K252515
Owner / Operator
- Firm Name
- Hebei Keylaser Sci-Tech Co., Ltd.
- Operator Number
- 10092883
- Address
- 4th Floor Building C18-2, HeGu Industry Park, Chaoyang East Road, ZhuoZhou
- City
- Baoding
- State
- Hebei
- Postal Code
- 072750
- Country
- CN
- Correspondent
- Zhen Yang
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2026-01-11 |
Proprietary Names
Q-Switched Nd:Yag laser (K690)
CO2 Laser Therapy System (K106)
Diode Laser Treatment System K16;Diode Laser Treatment System K17
Diode Laser Treatment System K22;Diode Laser Treatment System K22pro
Diode laser Treatment System K18
Diode Laser Treatment System K808;Diode Laser Treatment System K808pro
Diode Laser Treatment System K20A;Diode Laser Treatment System K21
Diode Laser Treatment System K17pro;Diode Laser Treatment System K18pro
Diode Laser Treatment System K19;Diode Laser Treatment System K20
Diode Laser Treatment System K23;Diode Laser Treatment System K23pro
Establishment Types
Manufacture Medical Device