BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    HDS HI 1.54

    K Number: K082799 · Decision Jan 27, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    15
    Review Days
    126

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    Basic Information

    Device Name
    HDS HI 1.54
    K Number
    K082799
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5916
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Paragon Vision Sciences
    Date Received
    September 23, 2008
    Decision Date
    January 27, 2009
    Product Code
    HQD
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HQD Lens, Contact (Other Material) - Daily

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    Other Clearances by Paragon Vision Sciences

    K Number Device Name
    K180172 FluoroPerm 30 & Paragon Thin (paflufocon C) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 60 & Paragon HDS (paflufocon B) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 92 (paflufocon A) RGP contact lenses with Tangible Hydra-PEG; FluoroPerm 151 & Paragon HDS 100 (paflufocon D) RGP contact lenses with Tangible Hydra-PEG
    K120996 FLUOROPERM 30 PARAGON HDS FLUOROPERM 60 PARAGON HDS 100 FLUOROPERM 92 FLUOROPERM 151 PARAGON THIN
    K070637 FLUOROPERM 92, 60, 30 AND 151 AND PARAGON HDS, HDS 100 AND THIN RIGID GAS PERMEABLE CONTACT LENSES
    K052983 FLUOROPERM 151 (PAFLUFOCON D) AND PARAGON HDS 100 (PAFLUFOCON D) RIGID GAS PERMEABLE CONTACT LENSES
    K013310 PVS BASIC 2; EPIC 2
    K010109 FLUOROPERM 151-OK, PARAGON HDS 100-OK
    K002845 PAFLUFOCON C AND E DAILY CONTACT LENS
    K993586 SPORTSIGHT GP
    K000224 FLUROPERM 60-OK, PARAGON HDS-OK
    K993486 PARAGON LENS CARRIER
    Search all 15 clearances from Paragon Vision Sciences →