BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Equator Plus ANF+ (VEPANF+)

    Reg #: 1528142 · FEI: 1000122772 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    45
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    VOLK OPTICAL INC.
    Registration Number
    1528142
    FEI Number
    1000122772
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    7893 ENTERPRISE DR.
    City
    Mentor
    State
    OH
    ZIP
    44060
    Country
    US

    Regulatory Submissions

    510(k) Number
    K943125

    Owner / Operator

    Firm Name
    VOLK OPTICAL INC.
    Operator Number
    9000705
    Address
    7893 ENTERPRISE DR.
    City
    Mentor
    State
    OH
    Postal Code
    44060
    Country
    US
    Correspondent
    Peter Chen

    Products

    Device Name Product Code
    Lens, Contact, Polymethylmethacrylate, Diagnostic HJK

    Proprietary Names

    Equator Plus ANF+ (VEPANF+) Quad Pediatric (VQPED) Centralis Direct (VCD) QuadrAspheric ANF+ (VQFLANF+) HR Direct Bi-Concave (VHRDBCACS) Fundus (VFUNDUS) Iridectomy (VIRID) Fundus 20mm (VFUNDUS20) SuperMacula VIT (VSMACVIT) HR Direct HighMag Vit (VHRDHMACS) Mag Plus Iridectomy (VMPIRID) Central Retinal SSV (VCRLVITSSV) Mini Quad VIT (VMQVIT) QuadrAspheric (VQFL) Mini Quad XL VIT SSV (VMQXLVITSSV) HR Direct 1X Vit (VHRD1XACS) Super Quad 160 NF (VSQUAD160NF) Central Retinal Vit (VCRLVIT) Area Centralis NF (VACNF) Blumenthal SutureLysis (VBSL) Super Macula 2.2 (VSMAC2.2) Mini Quad SSV (VMQVITSSV) Centralis Direct ANF+ (VCDANF+) Blumenthal Iridotomy (VBIRID) Super Quad 160 (VSQUAD160) HR Centralis (VHRC) Idrees MidVitreous (VIMV) Capsulotomy (VCAPS) Equator Plus NF (VEPNF) HR Direct 1X NSR Vit (VHRD1XNSRACS) Mini Quad XL VIT (VMQXLVIT) Dynaview 156 VIT (VDVVIT) TransEquator (VTE) HR Direct HM NSR Vit (VHRDHMNSRACS) HR Wide Field (VHRWF) QuadrAspheric NF (VQFLNF) HR Direct Prism Vit (VHRD20PACS) TransEquator NF (VTENF) Area Centralis (VAC) HRX SSV Vit (VHRXVITSSV) TransEquator ANF+ (VTEANF+) Area Centralis ANF+ (VACANF+) HRX Vit (VHRXVIT) PDT Laser (VPDT) Singh MidVitreous (VSMV)

    Establishment Types

    Manufacture Medical Device