Class Class II

Optima Coil System (OptiOne Coil System) (K254221)

K254221 2026-01-27 Special
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Description

Optima Coil System (OptiOne Coil System) by Balt USA, LLC, an FDA 510(k) cleared neurology device.

Regulatory Information

Device ClassClass Class II
510(k) NumberK254221
Clearance Date2026-01-27
Clearance TypeSpecial
Product CodeHCG
Regulation Number882.5950

Categories

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