FDA applicant
Hathor Professional Skincare, Ltd.
FDA records 3 decisions for Hathor Professional Skincare, Ltd. (Victoria, CA) from 2025 to 2026: 3 510(k) clearances. All are in product code NUC (Lubricant, Personal). Since 2016 its 510(k)s took a median of 244 days from receipt to decision, against 221 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Hathor Professional Skincare, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Hathor Professional Skincare, Ltd.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.
See the 510(k) Report