510(k) K232653

Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX by Blue Sky Bio, LLC — Product Code NXC

K232653 is an FDA 510(k) premarket notification submitted by Blue Sky Bio, LLC for the device "Blue Sky Plan Software, Blue Sky Bio Aligner Z, and Blue Sky Bio Aligner Z FLX". The FDA issued a decision of Substantially Equivalent on April 3, 2024. 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.