đź“‹ FDA Reference
Optima Coil System (OptiOne Coil System)
Balt USA, LLC
FDA Clearance Information
Pathway
510K
Number
K254221 ↗
Decision Date
January 27, 2026
Product Code
HCG
Device Class
Class 2
Evidence
0 studies
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.