Hebei Keylaser Sci-Tech Co., Ltd
Active in EUDAMEDChinafrom EUDAMED address EUDAMED FDA SRN CN-MF-000055451 FEI 3037047060
- Devices
- 3
- Registrations
- EUDAMEDFDA
- FDA recalls
- 0
At a glance
Market reach
- European Union
- EUDAMED actor
- United States
- FDA FEI
What Hebei Keylaser Sci-Tech Co., Ltd makes
Hebei Keylaser Sci-Tech Co., Ltd manufactures CO₂ laser therapy systems for dermatological and cosmetic treatments, Q-switched Nd:YAG lasers for tattoo removal and pigmentation correction, and diode laser treatment systems for hair removal and vascular lesion therapy.
These devices are classified as Class II under FDA regulations and are listed via the 510(k) pathway. The company operates from the United States.
Catalogue
CO2 Laser Therapy System (K106) Ref K252519
Regimes: 510(k) Registry: 510(k)Q-Switched Nd:Yag laser (K690) Ref K252515
Regimes: 510(k) Registry: 510(k)Diode laser Treatment System (K18) Ref K241498
Regimes: 510(k) Registry: 510(k)
Company details
- EUDAMED SRN
- CN-MF-000055451
- FDA FEI number
- 3037047060
- EUDAMED status
- Active
- EUDAMED registered name
- HEBEI KEYLASER SCI-TECH CO., LTD.
- Address
- 4th Floor Building C18-2, HeGu Industry Park, Chaoyang East Road, ZhuoZhou, Baoding Hebei
- [email protected]
- PRRC contact
- Zhen Yang
Frequently asked questions
How many devices does Hebei Keylaser Sci-Tech Co., Ltd have in the registry?
The registry currently lists 3 devices for Hebei Keylaser Sci-Tech Co., Ltd. Devices recorded under merged duplicate company entries are counted once.
Which registries list Hebei Keylaser Sci-Tech Co., Ltd's devices?
Among its 3 most recently registered devices, Hebei Keylaser Sci-Tech Co., Ltd has devices listed in FDA 510(k) (3 devices).
What risk classes do Hebei Keylaser Sci-Tech Co., Ltd's devices fall under?
Among its 3 most recently registered devices, the classes recorded for Hebei Keylaser Sci-Tech Co., Ltd's devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Hebei Keylaser Sci-Tech Co., Ltd in the registry?
The most recently registered devices listed for Hebei Keylaser Sci-Tech Co., Ltd include CO2 Laser Therapy System (K106), Q-Switched Nd:Yag laser (K690) and Diode laser Treatment System (K18).