510(k) Report

Devices descending from K200030

6 later devices reach Optima Coil System through their predicates, nearest generation first.

GenerationNumberDeviceApplicantDecidedOwn descendantsRecalls
+1K223386Optima Coil SystemBalt USA, LLC202231
+1K220699Prestige Coil SystemBait USA, LLC202212
+2K251383Prestige Coil System (Prestige Packing Line Extension)Balt USA, LLC20250—
+2K242582Optima Coil System (OptiBlock Line Extension)Balt USA, LLC20242—
+3K252700Optima Coil System (Optima Packing Coil System)Balt USA, LLC20251—
+4K254221Optima Coil System (OptiOne Coil System)Balt USA, LLC20260—