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510(k) Data Aggregation

    K Number
    K051876
    Device Name
    MULTIWAVE XR
    Date Cleared
    2005-09-09

    (60 days)

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

    PACIFIC QUANTUM INSTRUMENTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MultiWave XR Laser System is indicated for the following uses: 1. The 532 nm wavelength is indicated for: the treatment of Acne, benign vascular, including telangiectasia on the leg and face. 2. The 755 nm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for I-IV skin types. It is also indicated for the treatment of vascular lesions, benign pigmented lesions, and wrinkles. 3. The 1064 nm wavelength is indicated for: stable long-term or permanent hair reduction. It is used for IV-VI skin types. It also indicated for photocoagulation and hemostasis of dermatological vascular lesions, for incision/excision of soft body tissues in dermatology, and for nonablative wrinkle reduction.
    Device Description
    The MultiWave XR combines three laser outputs in a single device. It produces a long pulse laser light of 532 nm, 755 nm, and 1064 nm wavelengths. The laser head has two optical cavities containing an Alexandrite crystal rod (755 nm) and a Nd:YAG crystal rod (1064 nm) with optional frequency doubler installed (532 nm). Pulsed laser energy accomplished with a red aiming beam of low energy (5mW, 635nm) is delivered to a target via an optical fiber and a handpiece. Each laser outlet has own fiber and handpiece. Chilled air is delivered to the same target via jets in a handpiece.
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