Not currently registered with FDA under this name
Lumalite, Inc.
Los Angeles, CA, United States. Named as applicant on 3 dental 510(k) clearances between 1999 and 2002. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 31999–2002
- Markets registered in
- 24 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 1990–2026
Registered in 2 markets
Where regulators' registries name Lumalite, Inc. 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 | Lumalite, Inc. | 3 clearances | 1999–2002 | Below |
| South Korea | MFDS | Manufacturer | Lumalite, IncLumaLite, Inc. | 4 | 2005–2006 | 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 Lumalite, Inc. as the applicant.
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.