Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K013047
    Device Name
    FOTONA DUALIS ND:YAG LASER SYSTEM, FOTONA TWINLIGHT ND:YAG LASER SYSTEM
    Manufacturer
    Date Cleared
    2001-12-06

    (87 days)

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

    MOJCA VALIJAVEC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The family of Fotona DUALIS Nd:YAG laser systems is indicated for use in surgical and aesthetic applications requiring selective photothermolysis of target chromophores in soft tissue in the medical specialities of general and plastic surgery and dermatology: - To effect stable long-term, or permanent, hair reduction in skin types I VI through . selective targeting of melanin in hair follicles. Permanent hair reduction is defined as a longterm stable reduction in the number of hairs regrowing after a treatment regimen. - For removal of unwanted hair. ◆ - For coagulation and hemostasis of vascular lesions. - For incision/excision of soft body tissue in dermatology . - For soft tissue general surgery applications skin incision, tissue dissection; complete or partial resection of internal organs, tumors, lesions; tissue ablation; vessel coagulation
    Device Description
    The family of Fotona Dualis systems is based on the Nd: YAG laser technology. Within the systems, an optical cavity contains the Nd: YAG crystal, which is activated by means of the use of flashlamps. After the cavity, a red diode aiming beam is reflected onto a coaxial beam path using a beamsplitter assembly. The combined therapeutic and aiming bearns are guided down an optical fiber delivery system to a focusing handpiece. The laser is used in non-contact mode.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1