BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SIRONA 100 (aka EVANLAS) Therapy Laser System - Podiatry

    Reg #: 3033274371 · FEI: 3033274371 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    2

    Registration Details

    Registration Name
    CURE POINT THERAPEUTICS, INC
    Registration Number
    3033274371
    FEI Number
    3033274371
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    1712 Pioneer Avenue, Suite 2606
    City
    Cheyenne
    State
    WY
    ZIP
    82001
    Country
    US

    Regulatory Submissions

    510(k) Number
    K231997

    Owner / Operator

    Firm Name
    Cure Point Therapeutics, Inc
    Operator Number
    10091897
    Address
    1712 Pioneer Avenue, Suite 2606
    City
    Cheyenne
    State
    WY
    Postal Code
    82001
    Country
    US
    Correspondent
    Dr. Harold Kraft

    Products

    Device Name Product Code
    Lamp, Infrared, Therapeutic Heating ILY
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    SIRONA 100 (aka EVANLAS) Therapy Laser System - Podiatry SIRONA 100 (aka EVANLAS) Therapy Laser System

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility