Volk Optical Inc
FDA Regulatory Profile
Volk Optical Inc appears in FDA public data with 4 recalls, 4 510(k) clearances, 4 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-1177-2016, Class III) was initiated on February 2, 2016. Its most recent 510(k) clearance was granted on August 18, 2015.
Summary
- Total Recalls
- 4
- 510(k) Clearances
- 4
- Inspections
- 4
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-1177-2016 | Class III | Volk G-4 Small Ring, No Flange, Gonio Lens with case, UPC: 811608013602 for use as diagnostic conta | February 2, 2016 |
| Z-1685-2015 | Class III | Volk 25D Large Clear BIO Lens with case UPC: 8 11608 01010 6, VOLK OPTICAL INC. The Volk Optical BI | February 27, 2015 |
| Z-2055-2015 | Class III | Lombart 90D Clear with case Visualization during diagnosis and laser therapy of the human retina (f | February 27, 2015 |
| Z-0966-2013 | Class III | 20 Diopter Binocular Indirect Ophthalmoscope (BIO) Lens For visualization during diagnosis and la | October 25, 2012 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K151961 | Volk Disposable Iridotomy Lens, Volk Disposable Capsulotomy Lens | August 18, 2015 |
| K050623 | VOLK DISPOSABLE VITRECTOMY LENSES, MODELS VOLK FLAT SSV D, VOLK AFX SSV D, VOLK 45 PRISM SSV D | March 28, 2005 |
| K023221 | CONTACT LASER & DIAGNOSTIC LENSES | October 11, 2002 |
| K943125 | QUADRASPHERIC FUNDUS LENS | September 2, 1994 |