FDA applicant
Home Skinovations, Ltd.
FDA records 15 decisions for Home Skinovations, Ltd. (Yokneam, IL) from 2008 to 2023: 14 510(k) clearances and 1 De Novo grant. Most are in product codes OHT (Light Based Over-The-Counter Hair Removal) and ILY (Lamp, Infrared, Therapeutic Heating). Since 2016 its 510(k)s took a median of 136 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 26 predicates, 8 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 Home Skinovations, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2008.
Planning a device like Home Skinovations, 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