510(k) K151961

Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens by Volk Optical, Inc. — Product Code HJK

K151961 is an FDA 510(k) premarket notification submitted by Volk Optical, Inc. for the device "Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens". The FDA issued a decision of Substantially Equivalent on August 18, 2015. The device falls under product code HJK (Lens, Contact, Polymethylmethacrylate, Diagnostic), a Class II device regulated under 21 CFR 886.1385. Volk Optical, Inc. has at least 3 other 510(k) clearances on record.