Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K200693
    Device Name
    K2 MOBILE
    Manufacturer
    HULASER, Inc.
    Date Cleared
    2020-11-19

    (248 days)

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

    HULASER, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    K2 mobile laser is intended for use by dentists for excision, vaporization, ablation and coagulation of oral soft tissue procedures, including Tooth Whitening and the temporary relief of pain. The Specific indications are as follows: Endodontic procedures: Pulpotomy, Root canal therapy Periodontal procedures: Sulcular debridement Implant procedures: Implant recovery Surgery procedures: Biopsies, Crown lengthening, Exposure of unerupted teeth, Fibroma removal, Frenectomy, Gingivoplasty, Incision and drainage of abscess, Operculectomy, Papillectomies, Reduction of gingival hypertrophy, Vestibuloplasty Other procedures: Gingival troughing, Hemostasis and coagulation, Leukoplakia, Treatment of aphthous-ulcer canker sores and herpetic, Laser Assisted whitening, Topical heating for the purpose of elevating tissue temperary relief of minor muscle and joint pain and stiffness minor arthritis pain, or muscle spasm, minor muscular back pain; the temporary increase in local blood circulation; the temporary relation of muscle
    Device Description
    The dental diode laser (Model: K2 MOBILE) is a surgical device designed for a wide variety of dental soft tissue procedures. Diode laser is used as a source of invisible infrared radiation for this device and delivered to the treatment area through optical fiber is incorporated into a tip. The dental diode laser (Model: K2 MOBILE) is handpiece type using an internal rechargeable battery. The rechargeable battery charger are provided.
    Ask a Question

    Page 1 of 1