510(k) K161671

Ponto 3, Ponto 3 Power and Ponto 3 SuperPower by Oticon Medical AB — Product Code LXB

K161671 is an FDA 510(k) premarket notification submitted by Oticon Medical AB for the device "Ponto 3, Ponto 3 Power and Ponto 3 SuperPower". The FDA issued a decision of Substantially Equivalent on September 29, 2016. 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.