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

    PVS BASIC 2; EPIC 2

    K Number: K013310 · Decision Apr 25, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    34
    Registration Numbers
    34
    Same Product Code
    117
    Applicant Total
    15
    Review Days
    203

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PVS BASIC 2; EPIC 2
    K Number
    K013310
    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
    October 4, 2001
    Decision Date
    April 25, 2002
    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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (HQD), ordered by most recent decision date.

    GPA (hexafocon A) Rigid Gas Permeable Contact Lenses

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Acuity 181™ (tisilfocon A) and Acuity 181™ (tisilfocon A) with Tangible™ Hydra-PEG® Rigid Gas Permeable Contact Lenses

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    SDJMASTERVISION (fluoroxyfocon A) Rigid Gas Permeable Contact Lenses

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    BostonSight® Specialty Lenses

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Visionary Optics Scleral Contact Lens (roflufocon D, roflufocon E, hexafocon A, hexafocon B, tisilfocon A, fluoroxyfocon A)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    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
    K082799 HDS HI 1.54
    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
    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 →