BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Frax 1940

    DI: 00817495023489 · Model: 9APP7908 · Candela Corporation
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Frax 1940
    Primary DI
    00817495023489
    Version / Model
    9APP7908
    Company Name
    Candela Corporation
    Labeler DUNS
    053468385
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2022-02-09
    Public Version
    3
    Public Version Date
    2023-02-03
    Public Version Status
    Update
    Public Device Record Key
    688349dc-a45b-47f6-bd6f-196eb15ca79c

    Device Description

    Frax 1940 ( Laser)

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    No
    Over the Counter (OTC)
    No
    Kit
    No
    Combination Product
    No
    HCT/P
    No
    Contains NRL
    No
    Not Made with NRL
    No
    MRI Safety
    Labeling does not contain MRI Safety Information
    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
    GEX Powered Laser Surgical Instrument

    GMDN Terms

    Code Name
    45220 Multi-modality skin surface treatment system

    Identifiers

    Type ID
    Primary 00817495023489

    Premarket Submissions

    Submission Number Supplement Number
    K192951 000
    K212492 000