BEUDAMED
    FDA Registration Active 🇺🇸 United States

    OCULUS SURGICAL INC

    Reg #: 3009773841 · FEI: 3009773841 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    14
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    OCULUS SURGICAL INC
    Registration Number
    3009773841
    FEI Number
    3009773841
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    9850 SW Discovery Way
    City
    Port St Lucie
    State
    FL
    ZIP
    34987
    Country
    US

    Regulatory Submissions

    510(k) Number
    K051630

    Owner / Operator

    Firm Name
    Oculus Surgical Inc
    Operator Number
    10042000
    Address
    9850 SW Discovery Way
    City
    Port St Lucie
    State
    FL
    Postal Code
    34987
    Country
    US
    Correspondent
    Michael Krakowiecki

    Products

    Device Name Product Code
    Tray, Surgical, Instrument FSM
    Lens, Contact, Polymethylmethacrylate, Diagnostic HJK
    Retractor, Ophthalmic HNI
    General Surgery Tray LRO
    Prism, Gonioscopic HKS
    Lens, Condensing, Diagnostic HJL

    Proprietary Names

    Tray, Surgical, Instrument SUPER VIEW® Lens Set, Disposable SUPER VIEW® Lens Set, Disposable, Pivot Plus SUPER VIEW® Lens, Disp. Contact, Hassan-Tornambe SUPER VIEW® Lens Set, Disposable HD Plus, for RESIGHT Contact Lens, HD Professional, Cohen-Benner Contact "CBC" SUPER VIEW® Tornambe Contact Lens General surgery tray GONIO ready® CL SUPER VIEW® Lens Set, Disposable, Pivot SUPER VIEW® Lens Set, Disposable, Essential SUPER VIEW® Lens Set, Disposable HD, for RESIGHT Super View® Lens Set, Disposable, Pivot, for BIOM ml/cl VERSA HD Disposable LenZ

    Establishment Types

    Manufacture Medical Device Manufacture Medical Device for Another Party (Contract Manufacturer)