Not currently registered with FDA under this name
Home Skinovations , Ltd.
Yokneam, Israel. Named as applicant on 2 dental 510(k) clearances between 2020 and 2023. No establishment is registered with FDA under this exact name today.
- Device types listed
- 0
- Brands and models
- 0
- 510(k) clearances
- 22020–2023
- Markets registered in
- 412 registrations outside the US
- Establishments
- 0—
510(k) clearances per year, 2007–2026
Registered in 4 markets
Where regulators' registries name Home Skinovations , 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 | Home Skinovations , Ltd. | 2 clearances | 2020–2023 | Below |
| Israel | AMAR | Registration holder | Home Skinovations Ltd. | 10 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | HOME SKINOVATIONS LTD., | 1 | 2014–2014 | Pure Global AI |
| Canada | Health Canada | Registration holder | HOME SKINOVATIONS CORP. | 1 | 2015–2015 | 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 Home Skinovations , Ltd. as the applicant.
| Decided | 510(k) | Device | Device type |
|---|---|---|---|
| 13 Jan 2023 | K214078 | Silkn Toothwave | QMJ Powered Radiofrequency Toothbrush |
| 17 Sep 2020 | DEN190039 | ToothWave | QMJ Powered Radiofrequency Toothbrush |
Some of these clearances are listed with FDA today by another company: Silk'n Beauty Ltd. (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.