BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Erchonia XLR8 ; Erchonia XLR8 - Reman ; Erchonia HLS2 ; Erchonia HLS2-RM

    Reg #: 2032513 · FEI: 3003462036 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    3
    Classifications
    1

    Registration Details

    Registration Name
    ERCHONIA CORPORATION
    Registration Number
    2032513
    FEI Number
    3003462036
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    112 Southchase Blvd
    City
    Fountain Inn
    State
    SC
    ZIP
    29644
    Country
    US

    Regulatory Submissions

    510(k) Number
    K211186

    Owner / Operator

    Firm Name
    ERCHONIA CORPORATION
    Operator Number
    9047254
    Address
    112 Southchase Blvd, --
    City
    Fountain Inn
    State
    SC
    Postal Code
    29644
    Country
    US
    Correspondent
    Rebecca Tucek

    Products

    Device Name Product Code
    Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy NHN

    Proprietary Names

    Erchonia XLR8 ; Erchonia XLR8 - Reman ; Erchonia HLS2 ; Erchonia HLS2-RM

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Remanufacture Medical Device Manufacture Medical Device