BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Surgical Goniotomy (VSGACS)

    Reg #: 1528142 · FEI: 1000122772 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    39
    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

    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
    Prism, Gonioscopic HKS

    Proprietary Names

    Surgical Goniotomy (VSGACS) G-4 Goniolaser Flange (VG4) Uncoated 3MirrorANF+ (VU3MIRANF+) Mini 4 Mirror ANF+ (V4MANF+) SLT (VSLT) G-4 HighMag Small Ring NF (VG4HMSNF) G-3 Goniofundus-Mini NF (VG3MININF) G-2 Trabeculum Flange (VG2) G-4 HighMag Large Ring NF (VG4HMLNF) G-4 HighMag 2in1 Handle NF (VG4HMHAN2) 3 Mirror No Flange (V3MIR) Uncoated 3 MirrorNF (VU3MIR) G-1 Trabeculum Flange (VG1) 3 Mirror ANF+ (V3MIRANF+) Disposable 4-Mirror (V4MIRD) G-3 Goniofundus NF (VG3NF) G-6 Mirror NF Large Ring (VG6LNF) G-2 Trabeculum NF (VG2NF) Disposable 3-Mirror (V3MIRD) G-3 Goniofundus Flange (VG3) G-4 Mirror NF Large Ring (VG4LNF) G-4 NF 2in1 Handle (VG4HAN2) G-4 HighMag Flange (VG4HM) G-4 Mirror NF Small Ring (VG4SNF) Transcend TVG Surgical Gonio (VTSTVG) Disposable SLT Box of 400 (VSLTD400) Disposable SLT (VSLTD) G-1 Trabeculum NF (VG1NF) G-6 NF 2in1 Handle (VG6HAN2) Disposable 3-Mirror Box of 400 (V3MIRD400) Disposable 4-Mirror box of 10 (V4MIRD10) Disposable SLT Box of 10 (VSLTD10) Disposable 4-Mirror box of 100 (V4MIRD100) Disposable 3-Mirror Box of 100 (V3MIRD100) Disposable 3-Mirror Box of 10 (V3MIRD10) Rapid SLT (VMSLT) Disposable SLT Box of 100 (VSLTD100) Disposable 4-Mirror box of 400 (V4MIRD400) Volk Vold Surgical Gonio Lens (VTSVVG)

    Establishment Types

    Manufacture Medical Device