Company ยท US
Volk Optical Inc
FDA 510(k) clearances and medical device recalls filed under this name, 1994 to 2015. Name variants (Inc, Corp, punctuation) are merged.
4510(k) clearances (0 in 12 months)
6recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Aug 18, 2015 | K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens Volk Optical, Inc. | HJK |
| Mar 28, 2005 | K050623 | VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D Volk Optical, Inc. | HJK |
| Oct 11, 2002 | K023221 | CONTACT LASER & DIAGNOSTIC LENSES Volk Optical, Inc. | HJK |
| Sep 2, 1994 | K943125 | QUADRASPHERIC FUNDUS LENS Volk Optical, Inc. | HJK |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 15, 2016 | Volk Optical Inc Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602
for use as diagnostic contact lenses for eye examinations (including the anterior chamber, trabecular meshwork, central retina, Terminated |
HJK | None listed |
| Jul 9, 2015 | Volk Optical Inc Lombart 90D Clear with case
Visualization during diagnosis and laser therapy of the human retina (fundus) using a slit lamp. Terminated |
HJI | None listed |
| May 28, 2015 | Volk Optical Inc Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BIO Lenses are intended for visualization during diagnosis and laser therapy of the human retina (fund Terminated |
HJK | K023221 |
| Mar 18, 2013 | Volk Optical Inc 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens
For visualization during diagnosis and laser therapy of the human retina (fundus) using a binocular indirect ophthalmoscope. Terminated |
HJL | None listed |
| Jul 21, 2009 | Volk Optical Inc G-4 HighMag Flange, Model #VG4HM. Standard Gonio Lens for High Magnification Static and Dynamic Gonioscopy. Terminated |
HKS | None listed |
| Jul 14, 2009 | Volk Optical Inc Optiflex Lens Positioning Unit (LPU) Product Code: 10970, for use in vitreoretinal ophthalmic surgical procedures. Terminated |
KYB | None listed |