BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Poly Pro

    DI: B3437000A2 · Model: Poly Pro Rejuv · Medtek Lighting Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Poly Pro
    Primary DI
    B3437000A2
    Version / Model
    Poly Pro Rejuv
    Company Name
    Medtek Lighting Corporation
    Labeler DUNS
    002692106
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-19
    Public Version
    2
    Public Version Date
    2020-07-07
    Public Version Status
    Update
    Public Device Record Key
    d4d78814-acbc-4d09-a784-bab4c4d8990c

    Device Description

    LED Light Therapy Device. Uses 1820 LEDs at 633nm to treat facial wrinkles. Available for use in Salons, Spas, Med Spas, Dermatology.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    Yes
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    MR Conditional
    Direct Marking Exempt
    No
    PM Exempt
    No
    Has Serial Number
    Yes
    Has Lot/Batch Number
    No
    Has Manufacturing Date
    Yes
    Has Expiration Date
    No
    Has Donation ID
    No

    Sterilization

    Is Sterile
    No
    Sterilization Prior Use
    No

    Product Codes

    Code Name
    OHS Light Based Over The Counter Wrinkle Reduction

    GMDN Terms

    Code Name
    62202 Blue/red/infrared phototherapy lamp

    Identifiers

    Type ID
    Primary B3437000A2

    Customer Contacts

    Phone
    518-747-3310
    Email
    [email protected]

    Premarket Submissions

    Submission Number Supplement Number
    K180875 000