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510(k) Data Aggregation

    K Number
    K150664
    Device Name
    NeoLas
    Manufacturer
    SHEAUMANN LASER, INC
    Date Cleared
    2015-12-22

    (281 days)

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

    SHEAUMANN LASER, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The NeoLas Er: Y A G laser, and its accessories, are in dentistry, dermatology and other surgical areas in the following procedures: In dentistry for: Endodontic Surgery (Root Amputation) Indications: · Root end preparation for retrofill amalgam or composite · Removal of pathological tissues (i.e. cysts, neoplasm or abscess) and hyperplastic tissues (i.e. granulation tissue) from around the apex. NOTE: Any tissue growth (i.e. cyst, neoplasm or other lesions) must be submitted to a qualified laboratory for histopathological evaluation Laser Periodontal Procedures: - · Full thickness flap - · Partial thickness flap - · Split thickness flap - · Laser soft tissue curettage - · Laser removal of diseased, inflamed and necrosed soft tissue within the periodontal pocket · Removal of highly inflamed edematous tissue affected by bacteria penetration of the pocket lining and junctional epithelium · Removal of granulation tissue from bony defects · Sulcular debridement (removal of diseased, inflamed or necrosed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) The NeoLas 810nm Soft Tissue laser and its accessories are intended for use on adult and pediatric patients in dentistry, dermatology and other surgical areas in the following procedures: Soft Tissue Indications including Pulpal Tissues* Incision, excision, vaporization, ablation and coagulation or oral soft tissues, including: - · Excisional and incisional biopsies - · Exposure of unerupted teeth - · Fibroma removal - · Flap preparation-incision of soft tissue to prepare a flap and expose the bone. - · Flap preparation-incision of soft tissue to prepare a flap and expose unerupted teeth (hard and soft tissue impactions) - · Frenectomy and frenotomy - · Gingival troughing for crown impressions - · Gingivectomy - · Gingivoplasty - · Gingival incision and excision - · Hemostasis and coagulation
    Device Description
    NeoLas is a portable, microprocessor controlled dual laser system with both ER: Y AG and Soft Tissue capabilities. The NeoLas provides treatment capabilities via two separate fiber jumper and handpiece assemblies; NeoLas1 (ER:YAG) and NeoLas2 (Soft Tissue).The NeoLas1 treatment delivery system emits a 2.94um infrared photon pulses that used in the treatment of various endodonic and soft tissue indications. The NeoLas2 treatment delivery system utilizes solid-state diode laser (GaAlAs) technology to emit constant wavelength and pulsed energy of 808nm to perform soft tissue treatments.
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    K Number
    K120938
    Device Name
    THE PL-1064 LASER SYSTEM
    Manufacturer
    SHEAUMANN LASER, INC
    Date Cleared
    2012-09-24

    (186 days)

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

    SHEAUMANN LASER, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PL-1064 laser, collimated handpiece will be indicated for ablation, vaporizing, excision, incision, and coagulation of soft tissue encountered in dermatology, plastic surgery, and podiatry including but not limited to plantar warts, periungual warts and telangiectasia. . The PL-1064 will also be indicated for the temporary increase of clear nail in patients with onychomycosis (e.g., derniatophytes Trichophyton rubrum and T. mentagrophytes, and/or yeasts Candida albicans, etc.).
    Device Description
    The Sheaumann PL-1064 is a medical grade, solid-state, infrared diode laser (AlGaAs). The laser is designed to deliver continuous or pulsed, infrared laser energy with a wavelength at 1064 nm. The touch screen display consists of a user interactive screens that allows selection of continuous, pulsed and the TMP/CLEAR NAIL/ Clear Nail modes of operation, repetition rates, aiming beam on/off, procedural information display keys, a Standby/Ready key, the manual emergency stop button and the master key switch. THE LASER SYSTEM: The laser system consists of a laser diode optical deck, cooling system, voltage power supply and system control electronics that include the touch screen control panel. The mail console: Contains major electrical components. DELIVERY SYSTEM: The reusable 1.0 mm collimated handpiece has been designed to deliver a spot size of 1.0 mm. Safety glasses/goggles and a safety sign are also provided with the PL-1064.
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