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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 5 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| 20D Large Clear, Red Ring | V20LC-RD | FDA UDI | Class I | Active |
| 40D Large Clear | V40LC | FDA UDI | Class I | Active |
| Iridectomy (VLUIRID) | VLUIRID | FDA UDI | Class II | Active |
| ROLS Reinverter - Leica | VROLS-L | FDA UDI | Class I | Active |
| 28D Large Clear, Gold Ring | V28LC-GD | FDA UDI | Class I | Active |
| Volk Pictor Plus VP2FA | VP2FA | FDA UDI | Class II | Active |
| Condenser Lens Replacement, 175 mm | 11275 | FDA UDI | Class I | Active |
| Volk Pictor VP1Handset, VP1RET and VP1ANT | VP1OPHK | FDA UDI | Class II | Active |
| Disposable Direct Image WideField (VWFD) | VWFD | FDA UDI | Class II | Active |
| Super 66®, Red Ring | VS66-RD | FDA UDI | Class I | Active |
| Digital Wide Field®, Black | VDGTLWF-BK | FDA UDI | Class I | Active |
| Alcon Vold TVG Surgical Gonio | VTSTVG | FDA UDI | Class I | Active |
| 90D Cielo | C90 | FDA UDI | Class I | Active |
| Pan Retinal 2.2 Limited Edition #2 | VPRC-LE2 | FDA UDI | Class I | Active |
| Disposable Direct Image 30 Prism (V30PD) | V30PD | FDA UDI | Class II | Active |
| HR Wide Field (VEHRWF) | VEHRWF | FDA UDI | Class II | Active |
| Volk Pictor VP1ANT | VP1ANT | FDA UDI | Class II | Active |
| HRX Vit (VHRXVIT) | VHRXVIT | FDA UDI | Class II | Active |
| 90D Clear, Gold Ring | V90C-GD | FDA UDI | Class I | Active |
| Mounting Kit, MediWorks SM621 | 12655 | FDA UDI | Class I | Active |
| Mounting Kit, Topcon OMS-800 | 12162 | FDA UDI | Class I | Active |
| Volk Pictor VP1Handset, VP1RET, VP1ANT, VP1OTO, & VP1DERM | VP1COMPK | FDA UDI | N/A | Active |
| Volk Pictor Plus VP2RET | VP2RET | FDA UDI | Class II | Active |
| Pictor Prestige - Fundus Kit (VPPHAND and VPPRET) | VPPFUNDUSK | FDA UDI | Class II | Active |
| Digital High Mag®, Purple | VDGTLHM-PE | FDA UDI | Class I | Active |
| 90D Clear, Silver Ring | V90C-SR | FDA UDI | Class I | Active |
| G-4 HighMag Flange | VG4HM | FDA UDI | Class I | Active |
| Single Use 3-Mirror Gonio | V3MIRD | FDA UDI | Class I | Active |
| Digital Wide Field® Limited Edition #2 | VDGTLWF-LE2 | FDA UDI | Class I | Active |
| Digital High Mag®, Gold | VDGTLHM-GD | FDA UDI | Class I | Active |
| 90D Limited Edition | V90C-LE | FDA UDI | Class I | Active |
| 14D Large Clear | V14LC | FDA UDI | Class I | Active |
| Merlin LPU for RA, 200 mm | 11172 | FDA UDI | Class I | Active |
| 28D Large Clear, Blue Ring | V28LC-BE | FDA UDI | Class I | Active |
| SuperField® Limited Edition | VSFNC-LE | FDA UDI | Class I | Active |
| Uncoated 3 Mirror NF | VU3MIR | FDA UDI | Class I | Active |
| Super Quad 160 NF (VSQUAD160NF) | VSQUAD160NF | FDA UDI | Class II | Active |
| iNview for iPhone 5s (VINVIEW-5S) | VINVIEW-5S | FDA UDI | Class II | Active |
| 90D Clear, Purple Ring | V90C-PE | FDA UDI | Class I | Active |
| Silver 28D | VSLV28 | FDA UDI | Class I | Active |
| Area Centralis ANF+ (VACANF+) | VACANF+ | FDA UDI | Class II | Active |
| Volk Pictor Plus VP2HAND, VP2RET and VP2ANT | VP2OPHK | FDA UDI | Class II | Active |
| Merlin Mount, Zeiss | 11408 | FDA UDI | Class I | Active |
| 20D Limited Edition #2 | V20LC-LE2 | FDA UDI | Class I | Active |
| Central Retinal SSV (VCRLVITSSV) | VCRLVITSSV | FDA UDI | Class II | Active |
| Merlin LPU for CLA, 200 mm | 11174 | FDA UDI | Class I | Active |
| Merlin Mount, Leica M690 | 12159 | FDA UDI | Class I | Active |
| Centralis Direct ANF+ (VCDANF+) | VCDANF+ | FDA UDI | Class II | Active |
| Vitreo Lens Handle Long | VVITHAN-LG | FDA UDI | Class I | Active |
| Blumenthal Iridotomy (VEBIRID) | VEBIRID | FDA UDI | Class II | 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.' |