Data / Medical devices / Canada / Hathor Professional Skincare Ltd.
Hathor Professional Skincare Ltd.: FDA-registered device maker in Victoria British Columbia, Canada, 2 510(k) clearances
Hathor Professional Skincare Ltd. is registered with the FDA (registration 3036802562) in Victoria British Columbia, Canada. It lists 1 device type. The FDA files 2 510(k) clearances under its listings, the newest dated May 2, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3036802562
- Address
- 2618 Roseberry Ave., Victoria British Columbia, Canada, V8R 3T7
- Owner or operator
- Hathor Professional Skincare Ltd. (10092729)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- February 14, 2025
- Registered through
- 2026
- Brand names listed
- Sutil Luxe Coconut Personal Lubricant, Sutil Luxe Mint Personal Lubricant, Sutil Luxe Personal Lubricant, Sutil Luxe Vanilla Personal Lubricant, Sutil Rich Personal Lubricant
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lubricant, Personal | NUC | 2 | Complaint file establishment, Manufacturer, Specification developer | 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 |
|---|---|---|---|---|---|---|
| May 2, 2025 | K250629 | Sutil Rich Personal Lubricant | NUC | Substantially Equivalent | Hathor Professional Skincare , Ltd. | accessdata.fda.gov |
| January 21, 2025 | K241443 | Sutil Luxe Personal Lubricant (models 1126, 0009, 0010, 0011); Sutil Luxe Vanilla Personal Lubricant (models 1119, 1120); Sutil Luxe Coconut Personal Lubricant (models 1121, 1122); Sutil Luxe Mint Personal Lubricant (models 1117, 1118) | NUC | Substantially Equivalent | Hathor Professional Skincare , Ltd. | accessdata.fda.gov |
Compare with other makers
Updated May 2, 2025. 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.