Volk Optical Inc

FDA Regulatory Profile

Summary

Total Recalls
4
510(k) Clearances
4
Inspections
4
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-1177-2016Class IIIVolk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic contaFebruary 2, 2016
Z-2055-2015Class IIILombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (fFebruary 27, 2015
Z-1685-2015Class IIIVolk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIFebruary 27, 2015
Z-0966-2013Class III20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and laOctober 25, 2012

Recent 510(k) Clearances

K-NumberDeviceDate
K151961Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy LensAugust 18, 2015
K050623VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV DMarch 28, 2005
K023221CONTACT LASER & DIAGNOSTIC LENSESOctober 11, 2002
K943125QUADRASPHERIC FUNDUS LENSSeptember 2, 1994