Data / Medical devices / Canada / Silkn Canada Corp.
Silkn Canada Corp.: FDA-registered device maker in WOODBRIDGE Ontario, Canada, 4 510(k) clearances
Silkn Canada Corp. is registered with the FDA (registration 3033793026) in WOODBRIDGE Ontario, Canada. It lists 7 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 30, 2023. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3033793026
- Address
- 4550 Highway 7 Unit 206, WOODBRIDGE Ontario, Canada, L4L4Y7
- Owner or operator
- SILKN CANADA CORP. (10093700)
- Roles
- Exporter to the US
- First device listed
- June 25, 2025
- Registered through
- 2026
- Brand names listed
- Flash & Go Pro, LED light therapy mask, Light based over the counter hair removal, Motion Premium, Silk'n 7, Silk'n Infinity, Silk'n Infinity Fast, Silk'n LED Neck Mask and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lamp, Infrared, Therapeutic Heating | ILY | 2 | Exporter to the US | accessdata.fda.gov |
| Light Based Over The Counter Wrinkle Reduction | OHS | 2 | Exporter to the US | accessdata.fda.gov |
| Light Based Over-The-Counter Hair Removal | OHT | 2 | Exporter to the US | accessdata.fda.gov |
| Over-The-Counter Powered Light Based Laser For Acne | OLP | 2 | Exporter to the US | accessdata.fda.gov |
| Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction | PAY | 2 | Exporter to the US | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Transcutaneous Electrical, Aesthetic Purposes | NFO | 2 | Exporter to the US | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| 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 |
| August 11, 2017 | K171433 | Silk'n Infinity | OHT | Substantially Equivalent | Home Skinovations , Ltd. | accessdata.fda.gov |
| October 17, 2014 | K141242 | GLIDE DEVICE | OHT | Substantially Equivalent | Home Skinovations , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Light Based Over-The-Counter Hair Removal
- All makers of Stimulator, Transcutaneous Electrical, Aesthetic Purposes
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Light Based Over The Counter Wrinkle Reduction
- All makers of Over-The-Counter Radiofrequency Coagulation Device For Wrinkle Reduction
- All makers of Over-The-Counter Powered Light Based Laser For Acne
Updated August 30, 2023. 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.