Hebei Keylaser SCI-Tech Co., Ltd.
Registered establishment in Baoding, Hebei, China. 1 device type, 3 clearances.
Hebei Keylaser SCI-Tech Co., Ltd. is a manufacturer holding a current FDA establishment registration. The registration covers Powered Laser Surgical Instrument. Its earliest product listing with the FDA dates from 2025.
1device type
3510(k) clearances
Registration
| Registered name | HEBEI KEYLASER SCI-TECH CO., LTD. |
|---|---|
| Status | Registered |
| Registration expires | 2026 |
| Registration number | 3037047060 |
| FEI number | 3037047060 |
| Establishment type | Manufacturer |
Location
| City | Baoding |
|---|---|
| Province | Hebei |
| Address | 4th Floor Building C18-2, HeGu Industry Park, Chaoyang East Road, ZhuoZhou |
| Postal code | 072750 |
| Country | China |
What It Makes
| Device type | Class | Listed under the names | Listed since | Chinese makers |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | Class 2 | Diode Laser Treatment System K17pro;Diode Laser Treatment System K18pro, Diode Laser Treatment System K19;Diode Laser Treatment System K20, Diode Laser Treatment System K808;Diode Laser Treatment System K808pro, Diode Laser Treatment System K23;Diode Laser Treatment System K23pro, Diode laser Treatment System K18, Diode Laser Treatment System K20A;Diode Laser Treatment System K21 and 4 more | 2025 | 92 |
Clearances
| Clearance | Decision date | Product code | Route | Held by |
|---|---|---|---|---|
| K252519 | 2025-11-07 | GEX | Traditional | This company |
| K252515 | 2025-11-06 | GEX | Traditional | This company |
| K241498 | 2024-11-18 | GEX | Traditional | This company |
From the Company
Published by the company on its own website, not by the FDA.
| Founded | 2007 |
|---|---|
| Main products | Diode laser hair removal, IPL, RF microneedle, CO2 laser, Q-switch laser |
| Certifications | CE, ISO quality management system |
| Export markets | 190+ countries globally |
| OEM and ODM | Offered |
Nearby Manufacturers
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.
The manufacturer named here can complete this record.