FDA applicant
iSMART Developments, Ltd.
FDA records 4 decisions for iSMART Developments, Ltd. (Birmingham, GB) from 2023 to 2026: 4 510(k) clearances. Most are in product codes OHS (Light Based Over The Counter Wrinkle Reduction) and ONE (Powered Light Based Non-Laser Surgical…). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 88 for FDA’s reviews in the same codes and years. Its devices cite 6 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 iSMART Developments, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2023.
Planning a device like iSMART Developments, 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) ReportOther applicant names beginning “iSMART”
FDA records each applicant name separately; these may or may not be the same firm.