Shenzhen Hanhua Opto Co., Ltd.
ChinaFDA applicant, unverified FDA FEI 3013995763
- Devices
- 1
- Registrations
- FDA
- FDA recalls
- 0
At a glance
Market reach
- United States
- FDA FEI
What Shenzhen Hanhua Opto Co., Ltd. makes
Shenzhen Hanhua Opto Co., Ltd. manufactures LED therapy lights, including models such as the COB1400 and HP1800PRO, designed for medical or therapeutic applications.
These devices are classified as Class II under regulatory frameworks and are listed in the FDA’s 510(k) registry. The company is based in the United States.
Catalogue
LED Therapy Light (COB1400, HP1800PRO) Ref K253874
Regimes: 510(k) Registry: 510(k)
Company details
- FDA FEI number
- 3013995763
- Address
- 5F, Building A, YIshida Bao Yicheng Science and Technology park, Guanlan Street, Longhua District, Shenzhen, shenzhen Guangdong
Frequently asked questions
How many devices does Shenzhen Hanhua Opto Co., Ltd. have in the registry?
The registry currently lists 1 device for Shenzhen Hanhua Opto Co., Ltd.. Devices recorded under merged duplicate company entries are counted once.
Which registries list Shenzhen Hanhua Opto Co., Ltd.'s devices?
Among its 1 most recently registered device, Shenzhen Hanhua Opto Co., Ltd. has devices listed in FDA 510(k) (1 device).
What risk classes do Shenzhen Hanhua Opto Co., Ltd.'s devices fall under?
Among its 1 most recently registered device, the classes recorded for Shenzhen Hanhua Opto Co., Ltd.'s devices are Class II. Each device page shows its own class and authorisation.
What are the newest devices from Shenzhen Hanhua Opto Co., Ltd. in the registry?
The most recently registered devices listed for Shenzhen Hanhua Opto Co., Ltd. include LED Therapy Light (COB1400, HP1800PRO).