Is this your brand? Sign in to claim ownership.
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 3 of 7| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| Silver 90D | VSLV90 | FDA UDI | Class I | Active |
| Pan Retinal 2.2 Clear, Silver Ring | VPRC-SR | FDA UDI | Class I | Active |
| 78D Cielo | C78 | FDA UDI | Class I | Active |
| Central Retinal SSV ACS (VCRLVITSSVACS) | VCRLVITSSVACS | FDA UDI | Class II | Active |
| 78D Clear, Gold Ring | V78C-GD | FDA UDI | Class I | Active |
| 45 Prism SSV ACS (V45PRISMSSVACS) | V45PRISMSSVACS | FDA UDI | Class II | Active |
| G-1 Trabeculum NF | VG1NF | FDA UDI | Class I | Active |
| 28D Large Clear, Green Ring | V28LC-GN | FDA UDI | Class I | Active |
| G-2 Trabeculum NF | VG2NF | FDA UDI | Class I | Active |
| ROLS Reinverter - Zeiss | VROLS-Z | FDA UDI | Class I | Active |
| 28D Large Clear | V28LC | FDA UDI | Class I | Active |
| Mini Quad XL VIT (VMQXLVIT) | VMQXLVIT | FDA UDI | Class II | Active |
| TransEquator (VTE) | VETE | FDA UDI | Class II | Active |
| 28D Large Clear, Red Ring | V28LC-RD | FDA UDI | Class I | Active |
| Volk Viva | VVIVA1A | FDA UDI | Class II | Active |
| 78D Clear, Purple Ring | V78C-PE | FDA UDI | Class I | Active |
| Virtual by Volk Telemedicine Software | VTELEMED | FDA UDI | Class I | Active |
| G-4 HighMag 2in1 Handle NF | VG4HMHAN2 | FDA UDI | Class I | Active |
| Centralis Direct (VCD) | VCD | FDA UDI | Class II | Active |
| Merlin CLA Mount, Leica 690 | 11481 | FDA UDI | Class I | Active |
| Digital ClearField, Silver Ring | VDGTLCF-SR | FDA UDI | Class I | Active |
| HR Direct HighMag Vit (VHRDHMACS) | VHRDHMACS | FDA UDI | Class II | Active |
| Super Macula 2.2 (VSMAC2.2) | VSMAC2.2 | FDA UDI | Class II | Active |
| Digital ClearField, Purple Ring | VDGTLCF-PE | FDA UDI | Class I | Active |
| Hrx Ssv Acs (vhrxvitssvacs) | VHRXVITSSVACS | FDA UDI | Class II | Active |
| Volk SOLR Mid Field Lens | VSOLRMFL | FDA UDI | Class I | Active |
| Super 66® Limited Edition | VS66-LE | FDA UDI | Class I | Active |
| Digital Wide Field® Limited Edition | VDGTLWF-LE | FDA UDI | Class I | Active |
| Volk SOLR Lens Arm 175 | VSOLRLA175 | FDA UDI | Class I | Active |
| Iridectomy (VIRID) | VIRID | FDA UDI | Class II | Active |
| 78D Limited Edition | V78C-LE | FDA UDI | Class I | Active |
| Super 66®, Green Ring | VS66-GN | FDA UDI | Class I | Active |
| Pan Retinal 2.2 Clear, Green Ring | VPRC-GN | FDA UDI | Class I | Active |
| 30 Prism SSV ACS (V30PRISMSSVACS) | V30PRISMSSVACS | FDA UDI | Class II | Active |
| Pictor Prestige - Full Kit (VPPHAND, VPPRET and VPPANT) | VPPFULLK | FDA UDI | Class II | Active |
| Digital Wide Field®, Red | VDGTLWF-RD | FDA UDI | Class I | Active |
| 78D Limited Edition #2 | V78C-LE2 | FDA UDI | Class I | Active |
| Idrees MidVitreous (VEIMV) | VEIMV | FDA UDI | Class II | Active |
| Pan Retinal 2.2 Clear, Red Ring | VPRC-RD | FDA UDI | Class I | Active |
| Digital High Mag® | VDGTLHM | FDA UDI | Class I | Active |
| Merlin Mount, Takagi | 11412 | FDA UDI | Class I | Active |
| Afx Ssv Acs (vafxssvacs) | VAFXSSVACS | FDA UDI | Class II | Active |
| Single Use SLT | VSLTD | FDA UDI | Class I | Active |
| ROLS Infinity, Zeiss - Auto | 11363 | FDA UDI | Class I | Active |
| 90D Clear | V90C | FDA UDI | Class I | Active |
| Merlin CLA Mount, Zeiss MD | 11553 | FDA UDI | Class I | Active |
| G-4 Goniolaser Flange | VG4 | FDA UDI | Class I | Active |
| Central Retinal ACS (VCRLVITACS) | VCRLVITACS | FDA UDI | Class II | Active |
| Merlin LPU for RA, 175 mm | 11171 | FDA UDI | Class I | Active |
| SuperField® Limited Edition #2 | VSFNC-LE2 | FDA UDI | Class I | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
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.' |