510(k) K213733

Ponto 5 SuperPower by Oticon Medical AB — Product Code LXB

K213733 is an FDA 510(k) premarket notification submitted by Oticon Medical AB for the device "Ponto 5 SuperPower". The FDA issued a decision of Substantially Equivalent on December 16, 2021. The device falls under product code LXB (Hearing Aid, Bone Conduction), a Class II device regulated under 21 CFR 874.3302. Oticon Medical AB has at least 10 other 510(k) clearances on record.