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510(k) Data Aggregation

    K Number
    K990908
    Device Name
    MILLENNIUM
    Manufacturer
    ENDO TECHNIC CORP.
    Date Cleared
    1999-05-27

    (70 days)

    Product Code
    MXF
    Regulation Number
    872.4120
    Why did this record match?
    Applicant Name (Manufacturer) :

    ENDO TECHNIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use on adult and pediatric patients for the following: Class I, II, III, IV and V cavity preparation Caries removal Hard tissue surface roughening or etching Enameloplasty, excavation of pits and fissures for placement of sealants
    Device Description
    The Millennium™ hydrokinetic tissue cutting system is a diverse instrument for performing several dental applications. Millennium™ utilizes advanced laser and water atomization technologies to incise, excise and ablate intraoral soft and hard tissues safely and effectively. An erbium, chromium, yttrium, scandium, gallium garnet (Er, Cr:YSGG) solid state laser provides optical energy to a user controlled distribution of atomized water droplets. As the water droplets absorb the optical energy hydrokinetic cutting effects result. The hydrokinetic process refers to the removal of tissues with high speed, atomized water particles. Strong absorption of laser energy by atomized water droplets results in an intense yet controlled water particle micro-expansion and acceleration. The resulting hydrokinetic forces induce mechanical separation of surface material, vielding quick and clean mechanical tissue removal. A flexible fiberoptic handpiece delivers the Millennium™s unique hydrokinetic tissue cutting technology. A visible light emitted from the handpiece distal end pinpoints the area of treatment. The optical power output and atomized water spray distribution may be adjusted to specific user requirements.
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    K Number
    K971459
    Device Name
    DERMALASE
    Manufacturer
    ENDO TECHNIC CORP.
    Date Cleared
    1997-07-18

    (88 days)

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

    ENDO TECHNIC CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Use of the device is indicated for the incision, excision, ablation, vaporization and coagulation of dermatologic tissues including epidermal nevi, cheilitis, keloids, verrucae, skin tags, keratosis, scar revision, debulking of tumors, cysts, diagnostic biopsy and skin resurfacing. Use of the device is further indicated for the incision, excision, vaporization and coagulation of soft tissue during general surgical applications where skin incision, tissue disection, excision of external tumors and lesions, complete or partial resection of internal organs, tumors and lesions, tissue ablation and/or vessel coadulation may be indicated
    Device Description
    The DermaLase ™ laser system consists of two main components: the laser module and the delivery system. The Laser Module contains the laser resonator cavity, power supplies, closed loop internal cooling system and TTCS™ tissue irrigation and cooling module. Microelectronics circuits and system Control Panel are housed inside the laser console as well. The Control Panel provides access to all system controls. Actions are initiated through a touch sensitive membrane keypad. The display screen is back lighted for easy viewing. BioLase currently offers two options for laser energy delivery: a fiber optic based delivery system and an articulated arm based delivery system. The fiber optic system utilizes either a contact or non-contact hand piece. The articulated arm based delivery system utilizes either a contact or non-contact point delivery hand piece.
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