Clearance Summary
Optima Coil System (OptiOne Coil System) received FDA 510(k) clearance under submission number K254221, sponsored by Balt USA, LLC. The device was reviewed via the Special premarket notification pathway and assigned to the Neurology review panel. The statutory decision date of record is 2026-01-27.
- Submission: K254221
- Applicant / Sponsor: Balt USA, LLC
- Clearance pathway: Special
- Review panel: Neurology
- Device class: Class II
- Regulation citation: 21 CFR 882.5950
- Decision date: 2026-01-27
Classification & Regulation
This clearance is catalogued under FDA product code HCG and 21 CFR 882.5950, within the Neurology review panel as a Class II device.