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510(k) Data Aggregation

    K Number
    K242946
    Device Name
    HESTIA (L200-A)
    Manufacturer
    Date Cleared
    2025-10-03

    (373 days)

    Product Code
    Regulation Number
    878.4810
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The HESTIA is indicated for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary surgery.

    The HESTIA is indicated for use in the performance of specific surgical applications in aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynecology, and genitourinary surgery as follows:

    [Dermatology & Plastic Surgery]
    Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, &/or treatment of:

    • hemangiomas (including Buccal and port wine);
    • removal of small skin tumors;
    • milia;
    • basal and squamous cell carcinoma;
    • tricoepitheliomas;
    • syringoma

    Laser incision &/or excision of soft tissue for the performance of blepharoplasty.

    Laser incision &/or excision of soft tissue for the creation of recipient sites for hair transplantation

    [Podiatry]
    Laser ablation, vaporization &/or excision of soft tissue for the reduction, removal, &/or treatment of:

    • verrucae vulgares/plantar (warts);

    Laser ablation, vaporization and/or excision in podiatry for complete and partial matrixectomy;

    [Otolaryngology (ENT)]
    Laser incision, excision, ablation and/or vaporization of soft tissue in otolaryngology for treatment of:

    • polypectomy of nose and nasal passages;

    [Gynecology]
    Laser incision, ablation and/or vaporization of soft tissue in GYN for treatment of:

    • condyloma acuminata, including cervical, genital, vulvar and perineal;
    • hemangiomas

    [Genitourinary]
    Incision/excision and vaporization of soft tissue in genitourinary procedures.
    Applications include:

    • condyloma;
    • phimosis;
    Device Description

    This surgical laser is used for an operation to destroy and remove tissue by transmitting the optical energy of 10,600nm in wavelength, which is generated from the CO2 Laser tube, through a hand-piece. This device is composed of a hand-piece through which laser is output to the main body, articulated arm, foot switch, and power cord.

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