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Sign in to claim this brandVOLK OPTICAL INC.
US
Last updated September 17, 2026
Information
- Country
- US
- Address
- 7893 ENTERPRISE DR., Mentor, OH, 44060
- Website
- volk.com
- —
- —
- [email protected]
- Phone
- 440-942-6161
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- 1000122772
- DUNS Number
- 071125835
Catalogue (316)
Page 6 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| VistaView Slit Lamp Adapter | VVISTAVIEW2SLA | FDA UDI | Class I | Active |
| ROLS Reinverter - Zeiss + | VROLS-Z+ | FDA UDI | Class I | Active |
| Merlin RA Mount, Zeiss MD | 11552 | FDA UDI | Class I | Active |
| Merlin Small Diameter Wide Angle NC Lens | 11184 | FDA UDI | Class I | Active |
| Mid Field SSV ACS (VMFSSVACS) | VMFSSVACS | FDA UDI | Class II | Active |
| Volk Pictor Plus VP2ANT | VP2ANT | FDA UDI | Class II | Active |
| G-4 Mirror NF Small Ring | VG4SNF | FDA UDI | Class I | Active |
| SuperPupil® XL | VSPXL | FDA UDI | Class I | Active |
| G-3 Goniofundus NF | VG3NF | FDA UDI | Class I | Active |
| QuadrAspheric ANF+ (VQFLANF+) | VQFLANF+ | FDA UDI | Class II | Active |
| 20D Large Clear, Purple Ring | V20LC-PE | FDA UDI | Class I | Active |
| Dynaview 156 VIT (VDVVIT) | VDVVIT | FDA UDI | Class II | Active |
| ROLS Infinity, Leica - Auto | 11364 | FDA UDI | Class I | Active |
| Volk Pictor Plus VP2HAND and VP2ANT | VP2ANTK | FDA UDI | Class II | Active |
| MiniQuad SSV ACS (VMQVITSSVACS) | VMQVITSSVACS | FDA UDI | Class II | Active |
| G-4 HighMag Large Ring NF | VG4HMLNF | FDA UDI | Class I | Active |
| Hrx Acs (vhrxvitacs) | VHRXVITACS | FDA UDI | Class II | Active |
| Digital ClearField, Gold Ring | VDGTLCF-GD | FDA UDI | Class I | Active |
| Uncoated 3 Mirror ANF+ | VU3MIRANF+ | FDA UDI | Class I | Active |
| Digital Wide Field®, Gold | VDGTLWF-GD | FDA UDI | Class I | Active |
| 15D Large Clear | V15LC | FDA UDI | Class I | Active |
| HR Wide Field (VHRWF) | VHRWF | FDA UDI | Class II | Active |
| 20D Cielo | C20 | FDA UDI | Class I | Active |
| Disposable Direct Image BiConcave (VBCD) | VBCD | FDA UDI | Class II | Active |
| 3 Mirror ANF+ | V3MIRANF+ | FDA UDI | Class I | Active |
| Blumenthal SutureLysis (VBSL) | VBSL | FDA UDI | Class II | Active |
| Fundus (VFUNDUS) | VFUNDUS | FDA UDI | Class II | Active |
| Digital Wide Field®, Green | VDGTLWF-GN | FDA UDI | Class I | Active |
| Digital ClearField | VDGTLCF | FDA UDI | Class I | Active |
| Pan Retinal 2.2 Limited Edition | VPRC-LE | FDA UDI | Class I | Active |
| Merlin Mount, Inami | 11654 | FDA UDI | Class I | Active |
| Digital High Mag®, Black | VDGTLHM-BK | FDA UDI | Class I | Active |
| Volk SOLR Surgical System | VSOLR | FDA UDI | Class I | Active |
| Volk SOLR Rotation Base | VSOLRRB | FDA UDI | Class I | Active |
| Disposable Direct Image 1.5x Mag (VMD) | VMD | FDA UDI | Class II | Active |
| Pan Retinal 2.2 Clear | VPRC | FDA UDI | Class I | Active |
| Super VitreoFundus® | VSVF | FDA UDI | Class I | Active |
| Digital Wide Field® | VDGTLWF | FDA UDI | Class I | Active |
| SuperField® NC, Blue Ring | VSFNC-BE | FDA UDI | Class I | Active |
| QuadrAspheric (VQFL) | VQFL | FDA UDI | Class II | Active |
| G-1 Trabeculum Flange | VG1 | FDA UDI | Class I | Active |
| Digital ClearField, Red Ring | VDGTLCF-RD | FDA UDI | Class I | Active |
| Mag Plus Iridectomy (VMPIRID) | VMPIRID | FDA UDI | Class II | Active |
| Merlin Mount, Leica M822 | 12171 | FDA UDI | Class I | Active |
| 90D Limited Edition #2 | V90C-LE2 | FDA UDI | Class I | Active |
| Single Use Indirect Wide Field (VVITSSVDH) | VVITSSVDH | FDA UDI | Class II | Active |
| SuperMacula VIT (VSMACVIT) | VSMACVIT | FDA UDI | Class II | Active |
| Quad Pediatric (VQPED) | VQPED | FDA UDI | Class II | Active |
| Capsulotomy (VLUCAPS) | VLUCAPS | FDA UDI | Class II | Active |
| PDT Laser (VPDT) | VPDT | FDA UDI | Class I | Active |
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FDA Recalls (6)
Recalls reported by this firm to the FDA. Listed at company level — FDA recall records don't identify a specific catalogue device.
| Date | Recall No. | Class | Status | Reason |
|---|---|---|---|---|
| Feb 2, 2016 | Z-1177-2016 | — | terminated | The firm discovered that the incorrect lot number was engraved on the product. |
| Feb 27, 2015 | Z-1685-2015 | — | terminated | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. |
| Feb 27, 2015 | Z-2055-2015 | — | terminated | Mislabeling. The incorrect lot number was engraved on the anodized aluminum ring. The correct lot number is BE03356; however, BD03356 was engraved on the ring in error. |
| Oct 25, 2012 | Z-0966-2013 | — | terminated | The defect was with mis-engraving of the lot # directly on the product and its packaging. Mixed up device engraving of V20LC (lot # BB09213) with that from V60C (lot # BB09205). |
| Jan 23, 2009 | Z-1673-2009 | — | terminated | Lens may fall onto eye surface during procedure. Ophthalmologic device had a loose set screw on the Ball-Seal bushing assembly. As a result, the set screw becomes disengaged from the set screw groove in the bushing assembly and the Lens Positioning Unit slides downward. |
| Jun 30, 2008 | Z-1710-2009 | — | terminated | The ring of the Gonio lenses distributed was engraved as, 'G4 High Mag Gonio LNF'; however, the engraving should have read simply: 'G4 High Mag Gonio.' |