Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K043032
    Device Name
    DEALIGHT IPL
    Manufacturer
    Date Cleared
    2005-07-19

    (258 days)

    Product Code
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    EUROPRO, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Dealight Intense Pulsed Light (IPL) is indicated for use in surgical applications requiring selective photohermolysis (photocoagulation or coagulation) and hemostasis of soft tisse in the medical specialties of general and plastic surgery, and dermatology. Intense Pulsed Light Energy/Wavelengths (590-1200 nm) are indicated for: The removal of unwanted hair from all skin types, and to effect stable long-term, or permanent1, hair reduction in skin types I-V through selective targeting of melanin in hair follicles. 1 Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen.
    Device Description
    The Dealight Intense Pulsed Light (IPL) is comprised of the following main components: - A light / laser system console (including software and control electronics) - A control and display panel - Air cooling system - A hand-piece with cut off filters -
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1