Manufacturer registered with FDA
Silk'n Beauty Ltd.
Rotterdam, Netherlands. Lists 1 dental device type with FDA across 1 registered establishment.
- Device types listed
- 1
- Brands and models
- 1
- 510(k) clearances
- 0as applicant
- Markets registered in
- 551 registrations outside the US
- Establishments
- 1Netherlands
Registered in 5 markets
Where regulators' registries name Silk'n Beauty 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 | Manufacturer | Silk'n Beauty Ltd. | 1 device types | — | Below |
| Canada | Health Canada | Registration holder | SILK'N BEAUTY LTD. | 47 | 2008–2025 | Pure Global AI |
| Israel | AMAR | Manufacturer | Silkn beauty Ltd. | 2 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | Silk'n Beauty Ltd. | 1 | — | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | Silk'n Beauty Ltd | 1 | — | 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
Devices listed with FDA
What Silk'n Beauty Ltd. currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Powered Radiofrequency ToothbrushQMJ · Class 2 | — | Maker | powered radiofrequency toothbrush | 2023 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
Silk'n Beauty Ltd. lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Home Skinovations , Ltd. (1).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 17 Sep 2020 | DEN190039 | ToothWave | Home Skinovations , Ltd. | QMJ Powered Radiofrequency Toothbrush |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| SILK'N BEAUTY LTD.FDA reg. 3027645761 | Rotterdam Zuid-Holland, Netherlands | Manufacturer |
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10087179). 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.