Data / Medical devices / China / Shenzhen Hanhua Opto Co., Ltd.
Shenzhen Hanhua Opto Co., Ltd.: FDA-registered device maker in shenzhen Guangdong, China, 1 510(k) clearance
Shenzhen Hanhua Opto Co., Ltd. is registered with the FDA (registration 3013995763) in shenzhen Guangdong, China. It lists 2 device types. The FDA files 1 510(k) clearance under its listings, the newest dated March 3, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013995763
- Address
- 5F, Building A, YIshida Bao Yicheng Science and Technology park, Guanlan Street, Longhua District, Shenzhen, shenzhen Guangdong, China, 518000
- Owner or operator
- Shenzhen Hanhua Opto Co., Ltd. (10083913)
- Roles
- Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer
- First device listed
- December 30, 2021
- Registered through
- 2026
- Brand names listed
- AP1100A, AP1200, AP1800, AP300, AP600, BP180, C0B236, COB1320 and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Contract manufacturer, Exporter to the US, Foreign private label distributor, Manufacturer | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 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 |
|---|---|---|---|---|---|---|
| March 3, 2026 | K253874 | LED Therapy Light (COB1400, HP1800PRO) | OHS | Substantially Equivalent | Shenzhen Hanhua Opto Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Lamp, Infrared, Therapeutic Heating
- All makers of Light Based Over The Counter Wrinkle Reduction
Updated March 3, 2026. 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.