FDA applicant
Supervision Optimax Sdn Bhd
FDA records 2 decisions for Supervision Optimax Sdn Bhd (Sungai Buloh, MY) from 2017 to 2018: 2 510(k) clearances. All are in product code LPL (Lenses, Soft Contact, Daily Wear). Its devices cite 4 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 Supervision Optimax Sdn Bhd’s devices, and how often a recall has named them.
FDA decisions per year
1in 2018
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2017.
Planning a device like Supervision Optimax Sdn Bhd’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