BEUDAMED
    FDA UDI In Commercial Distribution 🇺🇸 United States

    Elite iQ PRO

    DI: 08034108512655 · Model: M122K1 · DEKA M.E.L.A. SRL
    View on AccessGUDID
    Product Codes
    1
    GMDN Terms
    1
    Identifiers
    1
    Pkg Device Count
    1

    Basic Information

    Brand Name
    Elite iQ PRO
    Primary DI
    08034108512655
    Version / Model
    M122K1
    Catalog Number
    M122K1
    Company Name
    DEKA M.E.L.A. SRL
    Labeler DUNS
    629381096
    Distribution Status
    In Commercial Distribution
    Device Count in Pkg
    1
    Record Status
    Published
    Publish Date
    2024-03-13
    Public Version
    1
    Public Version Date
    2024-03-21
    Public Version Status
    New
    Public Device Record Key
    b29944bf-6284-408f-aafe-1377aa7c5a95

    Device Description

    The Elite iQ PRO Laser System is indicated fot stable long-term or permanent hair reduction. Peramanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6, 9 or 12 months after the completiomn of a treatment regime. It is used for skin types (Fitzpatrick I-VI) including tanned skin. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 1064nm: The Elite iQ PRO Laser System is intended for the coagulation and hemostasis of benign vascular lesions such as, but not limited to, port wine stains, hemangiomas, warts, telangiectasia, rosacea, venous lakes, leg veins, spider wine and poikiloderma of Civatte; and treatment of benign cutaneous lesions such as, but not limited to, lentigines (age spots), solar lentigines (sunspots), cafe au lait macules, seborrheic keratoses, nevi, chloasma, verrucae, skin tags, keratosis and plaques. The laser is also indicated for the treatment of wrinkles such as, but not limited to, periocular and perioral wrinkles. Additionally, the laser is indicated for the treatment of psuedo folliculitis barbae (PFB) and for stable long-term or permanent hair reduction. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing when measured at 6,9 and 12 months after the competition of a treatment regime. The Skintel Reader is intended as an onbjective measurement tool for examing skin melanin content for determing and setting a test spot starting fluence.

    Device Characteristics

    Single Use
    No
    Prescription Use (Rx)
    Yes
    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 08034108512655

    Premarket Submissions

    Submission Number Supplement Number
    K240396 000

    Storage Conditions

    Type
    Handling Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Storage Environment Atmospheric Pressure
    Temperature Range
    70 – 106 KiloPascal
    Type
    Handling Environment Humidity
    Temperature Range
    20 – 80 Percent (%) Relative Humidity
    Type
    Handling Environment Temperature
    Temperature Range
    10 – 27 Degrees Celsius
    Type
    Storage Environment Humidity
    Temperature Range
    10 – 90 Percent (%) Relative Humidity
    Type
    Storage Environment Temperature
    Temperature Range
    5 – 50 Degrees Celsius