Data / Medical devices / China / Hebei Keylaser Sci-Tech Co., Ltd.
Hebei Keylaser Sci-Tech Co., Ltd.: FDA-registered device maker in Baoding Hebei, China, 3 510(k) clearances
Hebei Keylaser Sci-Tech Co., Ltd. is registered with the FDA (registration 3037047060) in Baoding Hebei, China. It lists 1 device type. The FDA files 3 510(k) clearances under its listings, the newest dated November 7, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3037047060
- Address
- 4th Floor Building C18-2, HeGu Industry Park, Chaoyang East Road, ZhuoZhou, Baoding Hebei, China, 072750
- Owner or operator
- Hebei Keylaser Sci-Tech Co., Ltd. (10092883)
- Roles
- Manufacturer
- First device listed
- March 3, 2025
- Registered through
- 2026
- Brand names listed
- CO2 Laser Therapy System (K106), Diode Laser Treatment System K16;Diode Laser Treatment System K17, Diode Laser Treatment System K17pro;Diode Laser Treatment System K18pro, Diode Laser Treatment System K19;Diode Laser Treatment System K20, Diode Laser Treatment System K20A;Diode Laser Treatment System K21, Diode Laser Treatment System K22;Diode Laser Treatment System K22pro, Diode Laser Treatment System K23;Diode Laser Treatment System K23pro, Diode Laser Treatment System K808;Diode Laser Treatment System K808pro and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Powered Laser Surgical Instrument | GEX | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 7, 2025 | K252519 | CO2 Laser Therapy System (K106) | GEX | Substantially Equivalent | Hebei Keylaser Sci-Tech Co.,Ltd | accessdata.fda.gov |
| November 6, 2025 | K252515 | Q-Switched Nd:Yag laser (K690) | GEX | Substantially Equivalent | Hebei Keylaser Sci-Tech Co.,Ltd | accessdata.fda.gov |
| November 18, 2024 | K241498 | Diode laser Treatment System (K18) | GEX | Substantially Equivalent | Hebei Keylaser Sci-Tech Co.,Ltd | accessdata.fda.gov |
Compare with other makers
Updated November 7, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.