Not currently registered with FDA under this name
Biolux Research , Ltd.
Vancouver, Canada. Named as applicant on 1 dental 510(k) clearance between 2015 and 2015. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 12015–2015
- Markets registered in
- 617 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 6 markets
Where regulators' registries name Biolux Research , Ltd. as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Applicant | Biolux Research , Ltd. | 1 clearances | 2015–2015 | Below |
| Canada | Health Canada | Registration holder | BIOLUX RESEARCH LTD. | 13 | 2008–2014 | Pure Global AI |
| Hong Kong | MDD | Manufacturer | Biolux Research Ltd. | 1 | 2017–2017 | Pure Global AI |
| Israel | AMAR | Manufacturer | BIOLUX RESEARCH LTD. | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | Biolux Research Ltd. | 1 | 2008–2008 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | Biolux Research Ltd | 1 | 2018–2018 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
510(k) clearances
Clearances on which FDA names Biolux Research , Ltd. as the applicant.
Some of these clearances are listed with FDA today by another company: Biolux Technology GmbH (1).
Sources
FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record of the most recent filing, which can be a US agent.