BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GOME OPTICAL LENS COMPANY LIMITED

    Reg #: 3015392301 · FEI: 3015392301 · Expires 2026
    View on FDA
    Products
    18
    Proprietary Names
    5
    Establishment Types
    3
    Classifications
    18

    Registration Details

    Registration Name
    GOME OPTICAL LENS COMPANY LIMITED
    Registration Number
    3015392301
    FEI Number
    3015392301
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    598 Tuckahoe Road
    City
    Yonkers
    State
    NY
    ZIP
    10710
    Country
    US

    Regulatory Submissions

    510(k) Number
    K070494

    Owner / Operator

    Firm Name
    Gome Optical Lens Company Limited
    Operator Number
    10060498
    Address
    598 Tuckahoe Road
    City
    Yonkers
    State
    NY
    Postal Code
    10710
    Country
    US
    Correspondent
    Eric C Rubinfeld

    Products

    Device Name Product Code
    Frame, Spectacle HQZ
    Device, Biofeedback HCC
    Accessory, Surgical Apparel LYU
    Powered Laser Surgical Instrument GEX
    Medical Device Data System OUG
    Unit, Heating, Powered IRQ
    Lens, Spectacle (Prescription), For Reading Discomfort NJH
    Pack, Hot Or Cold, Disposable IMD
    Respirator, Surgical MSH
    Digital Visual Acuity Test QTO
    Pack, Heat, Moist IMA
    Mmp-9 Test System PFQ
    Chart, Visual Acuity HOX
    Sunglasses (Non-Prescription Including Photosensitive) HQY
    Lens, Spectacle, Non-Custom (Prescription) HQG
    Shield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear) HOY
    Pad, Heating, Powered IRT
    Keratoscope, Ac-Powered HLQ

    Proprietary Names

    Disposable Medical Face Mask Surgical N95 Respirators DMV Eye Test DMVEyeTest DryEyeAnalyzer

    Establishment Types

    Repack or Relabel Medical Device Manufacture Medical Device Develop Specifications But Do Not Manufacture At This Facility