Data / Medical devices / Netherlands / Silk'n Beauty Ltd.
Silk'n Beauty Ltd.: FDA-registered device maker in Rotterdam Zuid-Holland, Netherlands, 12 510(k) clearances
Silk'n Beauty Ltd. is registered with the FDA (registration 3027645761) in Rotterdam Zuid-Holland, Netherlands. It lists 13 device types. The FDA files 12 510(k) clearances under its listings, the newest dated March 23, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3027645761
- Address
- Galileistraat 17, Rotterdam Zuid-Holland, Netherlands, 3029 AL
- Owner or operator
- Silk'n Beauty Ltd. (10087179)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- July 12, 2023
- Registered through
- 2026
- Brand names listed
- BellaFlash Pro, Brush, dermabrasion, powered, Electrosurgical, cutting & coagulation & accessories, FaceTite (Titan) Mini, FaceTite (Titan) MultiPlatform, FaceTite Mini, FaceTite MultiPlatform, Flash & Go Pro and more
Devices it lists
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 23, 2026 | K260202 | LED Light Therapy Masks (LumiLips FAC07NA) | OHS | Substantially Equivalent | Guangdong Newdermo Biotech Co., Ltd. | accessdata.fda.gov |
| August 30, 2023 | K230013 | Silk'n Titan Allways | PAY | Substantially Equivalent | Silk'N Beauty , Ltd. | accessdata.fda.gov |
| February 23, 2023 | K223544 | LED light therapy mask (FM-01, FM-02, FM-03) | OHS | Substantially Equivalent | Guangdong Newdermo Biotech Co., Ltd. | accessdata.fda.gov |
| September 17, 2020 | DEN190039 | ToothWave | QMJ | Unknown | Home Skinovations , Ltd. | accessdata.fda.gov |
| May 9, 2018 | K180279 | Silk'n MODEL H5003 device | NGX | Substantially Equivalent | Home Skinovations , Ltd. | accessdata.fda.gov |
| August 11, 2017 | K171433 | Silk'n Infinity | OHT | Substantially Equivalent | Home Skinovations , Ltd. | accessdata.fda.gov |
| March 25, 2017 | K162784 | Silk'n HST | OHS | Substantially Equivalent | Home Skinovations , Ltd. | accessdata.fda.gov |
| July 29, 2016 | K152087 | HeatLux Pro II | ILY | Substantially Equivalent | Home Skinovations , Ltd. | accessdata.fda.gov |
| October 17, 2014 | K141242 | GLIDE DEVICE | OHT | Substantially Equivalent | Home Skinovations , Ltd. | accessdata.fda.gov |
| February 22, 2013 | K121435 | SILKN BLUE | OLP | Substantially Equivalent | Home Skinovations , Ltd. | accessdata.fda.gov |
| August 19, 2011 | K110301 | SILK'N FX | OHS | Substantially Equivalent | Home Skinovations , Ltd. | accessdata.fda.gov |
| November 10, 2010 | K103184 | SILK'N FLASH N GO | OHT | Substantially Equivalent | Home Skinovations , Ltd. | accessdata.fda.gov |
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Updated March 23, 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.