FDA applicant
Medtek Skincare, LLC
FDA records 2 decisions for Medtek Skincare, LLC (Hudson, NY) from 2018 to 2019: 2 510(k) clearances. Most are in product codes OHS (Light Based Over The Counter Wrinkle Reduction) and OLP (Over-The-Counter Powered Light Based Laser For…). Its devices cite 3 predicates, 0 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 Medtek Skincare, LLC’s devices, and how often a recall has named them.
FDA decisions per year
1in 2019
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2018.
Planning a device like Medtek Skincare, LLC’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) ReportOther applicant names beginning “Medtek”
FDA records each applicant name separately; these may or may not be the same firm.