BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    POLY Go

    DI: B3437000CA1 · Model: POLY Go Clear · Medtek Lighting Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    POLY Go
    Primary DI
    B3437000CA1
    Version / Model
    POLY Go Clear
    Company Name
    Medtek Lighting Corporation
    Labeler DUNS
    002692106
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2018-09-17
    Public Version
    2
    Public Version Date
    2020-07-07
    Public Version Status
    Update
    Public Device Record Key
    7f0074f6-72c6-4b36-9a2b-489780dc5db0

    Device Description

    Hand Held LED Light Therapy Device. Uses LED to treat mild to moderate Acne. Contains rechargeable Battery

    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 Safe
    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
    OLP Over-The-Counter Powered Light Based Laser For Acne

    GMDN Terms

    Code Name
    62202 Blue/red/infrared phototherapy lamp

    Identifiers

    Type ID
    Primary B3437000CA1

    Premarket Submissions

    Submission Number Supplement Number
    K180900 000

    Device Sizes

    Type Value Unit Text
    Area/Surface Area 25 Square centimeter