FDA applicant
Oriental Inspiration Limited
FDA records 6 decisions for Oriental Inspiration Limited (Hong Kong, CN) from 2004 to 2024: 6 510(k) clearances. Most are in product codes KPI (Stimulator, Electrical, Non-Implantable, For…) and OHT (Light Based Over-The-Counter Hair Removal). Since 2016 its 510(k)s took a median of 154 days from receipt to decision, against 181 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.
FDA’s records also spell it “Oriental Inspiration, Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Oriental Inspiration Limited’s devices, and how often a recall has named them.
FDA decisions per year
1in 2024
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Oriental Inspiration Limited’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 “Oriental”
FDA records each applicant name separately; these may or may not be the same firm.