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510(k) Data Aggregation

    K Number
    K081612
    Device Name
    AESCULIGHT FAMILY OF FLEXIBLE FIBERS, HANDPIECES AND TIPS FOR CO2 SURGICAL LASERS
    Manufacturer
    AESCULIGHT, LLC
    Date Cleared
    2008-06-25

    (16 days)

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

    AESCULIGHT, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The intended use of the product(s) is to communicate the laser beam of a CO, surgical laser to the target site for the incision, excision, ablation, or photocoagualtion of soft tissue. Representative examples of clinical applications include: Gynecology--excision and vaporization of cervical, vulvar, and perineal condyloma: ablation of vaginal and vulvar intraepithelial neoplasia; herpes vaporization of urethral caruncle; I&D Bartholin's and nubothian cysts Dermatology--port wine hemangioma removal; rhinophyma reduction; telangiectasia removal; wart removal; basal squamous cell carcinomoa removal; blepharoplasty, xanthalasma removal; removal of neurofibromas hemangiomas, nevi, and tircoeptiheliomas; dermabrasion for lentigos, keratoses, actinic keratosis and actinic chleilitis Dentistry/Oral Surgery-gingivectomy; frenum release; gingivoplasty; removal of soft tissue, cysts, and tumors General Surgery--hemorthoid removal; skin tag vaporization; pilodidal cyst removal and repair; debridement of decubitus ulcers and stasis ulcers; mastectomy; breast biopsy, reduction mammoplasty; cytoreduction for metastatic disease; many dermatological procedures Laparoscopic Surgery--vaporization, incision, excision, ablation, or photo-coagulation of soft tissue such as endometriosis ablation, excision of adhesions, salpingotomy Otorhinolaryngology--lymphangioma removal; turbinectomy, subglottic stenosis vaporization, tonsilectomy, removal of vocal cord papillomas, nodules, and polyps Podiatry-plantar wart vaporization; fungal nail treatment; partial and complete mattixectomy; porokeratoma ablation; Morton's neurome removal; ingrown toenail treatment Orthopedic -- menisectorny, chondromalacia abalation, partial synovectomy, lateral release, PMMA removal No new indications for use are sought beyond those associated with the predicate devices.
    Device Description
    This is a family of detachable devices that comprise the distal portion of a beam delivery system to be used with a CO, surgical laser such as that described in K96075. Specifically, the devices consist of a flexible hollow lightpipe (fiber), handpieces that connect to the fiber, and various tips that connect to the handpieces. The tips are short, rigid hollow alumina lightpipes producing a variety of spot sizes. The user may "mix and match" handpieces and tips to suit the clinical task at hand.
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