510(k) K232339

Augmented Reality Application by Sira Medical, Inc. — Product Code LLZ

K232339 is an FDA 510(k) premarket notification submitted by Sira Medical, Inc. for the device "Augmented Reality Application". The FDA issued a decision of Substantially Equivalent on February 1, 2024. The device falls under product code LLZ (System, Image Processing, Radiological), a Class II device regulated under 21 CFR 892.2050.