510(k) K050623

VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D by Volk Optical, Inc. — Product Code HJK

K050623 is an FDA 510(k) premarket notification submitted by Volk Optical, Inc. for the device "VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D". The FDA issued a decision of Substantially Equivalent on March 28, 2005. 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.