Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K980501
    Device Name
    SKINTONER SYSTEM
    Date Cleared
    1998-07-08

    (149 days)

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

    FULLER RESEARCH CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The SkinLaser System is indicated for incision, excision, coagulation and vaporization of soft tissue. In general surgery, dermatologic and plastic surgery, all soft tissues are included in this indication: skin, subcutis, breast, abdominal and striated and smooth muscle, tendon and fascia, cartilage, mucous membrane, lymph vessels and nodes, and internal organs and glands. In gynecologic and urologic surgery indications include endoscopic, intraabdominal and externally accessed (free-hand) gynecological and urological tissues, structures, obstructions, strictures, tumors, and other lesions. Only palliative treatment and partial removal of neoplastic tissue should be assumed. In gastroenterology indications include destruction of polyps, lesions, varices, tumors, and for treatment of hemorrhages. In pulmonology surgery indications include flexible or a rigid endoscopic and free-hand access and treatment of soft tissue lesions, obstructions, tracheal stenosis, and tumors.
    Device Description
    The SkinLaser System is substantially equivalent to continuous wave (CW) and pulsed CW surgical lasers in the wavelength range of 800nm to 1064nm. Such systems have been in surgical use for many years offering broad multi-specialty, multi-procedure applications. The laser deliver system includes both contact and non-contact devices.
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1