Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K150587
    Device Name
    Cortex Laser System
    Manufacturer
    Cynosure, Inc. dba Ellman
    Date Cleared
    2015-07-21

    (134 days)

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

    Cynosure, Inc. dba Ellman

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CO2 laser is indicated for incision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology, neurosurgery, orthopedics, general and thoracic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing. The CO2 System is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery, general surgery. Dermatology, Plastic Surgery and General Surgery procedures: - · Laser skin resurfacing. - · Treatment of furrows and wrinkles. · Removal of skin tags, actinic keratosis, acne scars, keloids, tattoos, telangiectasia, squamous and basal cell carcinoma, warts and uneven pigmentation. - · Treatment of cysts, abscesses, hemorrhoids and other soft tissue applications. - · Blepharoplasty. - · Site preparation for hair transplants. - · The fractional scanner is for skin resurfacing. The Er: YAG handpiece is designed specifically for superficial skin ablation resulting in skin dermabrasion, and the treatment of wrinkles. In addition this system is intended for coagulation, ablation, or cutting of soft tissue (skin) in dermatology, plastic surgery (including aesthetic surgery).
    Device Description
    The Cortex system and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The CO2 laser is delivered via an articulated arm that is permanently attached to the console. The Er: Y AG handpiece attaches to a port on the console and contains the laser cavity in the head of the handpiece. The user interface is a touch screen located on the console. The user activates the laser emission by means of a footswitch.
    Ask a Question

    Page 1 of 1