510(k) K201909

RxSight Contact Lens by Rxsight, Inc. — Product Code HJK

K201909 is an FDA 510(k) premarket notification submitted by Rxsight, Inc. for the device "RxSight Contact Lens". The FDA issued a decision of Substantially Equivalent on September 10, 2020. The device falls under product code HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic), a Class II device regulated under 21 CFR 886.1385. Rxsight, Inc. has at least 5 other 510(k) clearances on record.