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510(k) Data Aggregation

    K Number
    K991628
    Device Name
    MODIFIED LX-20 CO2 LASER SYSTEM FAMILY, LX-20SA
    Manufacturer
    ESC MEDICAL SYSTEMS, INC.
    Date Cleared
    1999-08-09

    (90 days)

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

    ESC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The modified LX-20 Laser System Family is a general surgical instrument used to vaporize, incise, excise, ablate, or photo coagulate soft tissue in surgical procedures in the listed surgical specialties. The system may be effectively utilized for those applications recognized as within the accepted indications for use of C0, laser devices performed within the listed specialties and which require power densities as calculated by power and spot size referenced in the power density charts in the operator's manual. Indications for Use - Gynecology Representative examples: Condyloma, excision and vaporization, cervical, vulvar, & perineal; vaginal intraepithelial neoplasia ablation (VAIN); vulvar intraepithelial neoplasia ablation (VIN); herpes vaporization; urethral caruncle vaporization; I&D Bartholin's & nubothian cysts. Indications for Use - Laparoscopic Surgery Vaporization, incision, excision, ablation, or photo coagulation of soft tissue in endoscopic and laparoscopic surgery including GYN laparoscopy where delivery of energy by the hollow fiber may be more convenient than delivery of energy by a handpiece. Representative examples: endometriosis ablation; excision of adhesions; salpingotomy; metroplasty, Indications for Use - Dermatology Representative examples: Tattoo removal; port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; keloid reduction; wart removal; basal & squamous cell carcinoma removal; blepharoplasty; xanthalasma removal; removal of neurofibromas, hemangiomas, nevi, and tricoepitheliomas; dermabrasion such as for lentigos, keratoses, actinic keratosis & cheilitis. Indications for Use - Dental/Oral Surgery Representative examples: Gingivectomy; frenum release; removal of soft tissue, cysts, and tumors. Indications for Use - Orthopedic Representative examples: Menisectomy; chondromalacia ablation; partial synovectomy; lateral release; PMMA removal. Indications for Use - General Surgery Representative examples: Hemorthoid removal; skin tag vaporization; pilodidal cyst removal and repair: debridement of decubitus ulcers and statis ulcers; mastectomy, breast biopsy, reduction mammoplasty; cytoreduction for metastatic disease; many dermatological procedures. Indications for Use - Otorhinolaryngology (ENT) Representative examples: Subglottic stenosis vaporization; tonsillectomy; removal of vocal cord papillomas, nodules, and polyps; lymphangioma removal; pulmonary bronchial and tracheal lesion removal: turbinectomy; removal of leukoplakia of larynx; ablation of choanal atresia. Myringotomy/tympanostomy; Laser Assisted Uvulopalatoplasty (LAUP). Indications for Use - Podiatry Representative examples: Plantar wart vaporization; fungal nail treatment; partial and complete matrixectomy; porokeratoma ablation; Morton's neruoma removal; ingrown nail treatment.
    Device Description
    The Luxar modified LX-20 Surgical Laser System produces laser (infrared) energy at a wavelength of 10.6 microns which is directed to soft tissue through a knuckled beam delivery assembly, articulated arm or articulated arm plus hollow fiber waveguide, handpieces, and sterile delivery tips.
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    K Number
    K982827
    Device Name
    DERMA K ER:YAG/CO2 LASER
    Manufacturer
    ESC MEDICAL SYSTEMS, INC.
    Date Cleared
    1998-09-14

    (34 days)

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

    ESC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Derma™ K Laser System is intended for incision, ablation, vaporization, and hemostasis of soft tissue.
    Device Description
    Not Found
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    K Number
    K965015
    Device Name
    TOPAZ 30 SURGICAL LASER SYSTEM
    Manufacturer
    ESC MEDICAL SYSTEMS, INC.
    Date Cleared
    1997-03-14

    (88 days)

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

    ESC MEDICAL SYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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