510(k) K221845

Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G by Blue Sky Bio, LLC — Product Code NXC

K221845 is an FDA 510(k) premarket notification submitted by Blue Sky Bio, LLC for the device "Blue Sky Bio Aligner G & Blue Sky Plan S/W for Blue Sky Bio Aligner G". The FDA issued a decision of Substantially Equivalent on February 24, 2023. The device falls under product code NXC (Aligner, Sequential), a Class II device regulated under 21 CFR 872.5470. Blue Sky Bio, LLC has at least 10 other 510(k) clearances on record.