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510(k) Data Aggregation

    K Number
    K103118
    Device Name
    REVLITE Q-SWITCHED ND: YAG LASER SYSTEM WITH NADPIECE ADAPTOR
    Manufacturer
    HOYA PHOTONICS, INC.
    Date Cleared
    2010-11-19

    (29 days)

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

    HOYA PHOTONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use: Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology. Dermatologic and General Surgical Procedures for Coagulation and Hemostasis. Specific Indications: - 1064 nm wavelength - Tattoo Removal (dark ink: blue and black) - Dermal Pigmented Lesions - Nevus of Ota - Removal or lightening of hair with or without adjuvant preparation. - Skin Resurfacing for Acne Scars and Wrinkles - Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength) - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength) 532 nm wavelength (nominal delivered energy of 585 nm and 650 nm with the Optional Multilite Dye Laser Handpiece) - Tattoo removal (light ink: red, sky blue, green) - Vascular lesions including but not limited to: port wine birthmarks, telangiectasias, spider angioma, cherry angioma, spider nevi - Epidermal Pigmented lesions including but not limited to: cafe-au-lait birthmarks, solar lentiginos, senile lentiginos, Becker's nevi, Freckles, Nevus spilus - Skin Resurfacing for Acne Scars and Wrinkles - Benign cutaneous lesions, such as, but not limited to: striae and scars (excludes the 650nm wavelength) - Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar (excludes the 650nm wavelength)
    Device Description
    The RevLite Q-Switched Nd:YAG Laser System with Handpiece Adaptor consists of a electrically powered Console in which laser energy produced within the system is delivered to the tissue by means of an articulated arm, Handpiece Adaptor and specially designed Handpieces. The user activates laser emission by means of a footswitch.
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    K Number
    K050696
    Device Name
    MEDLITE C1 Q-SWITCHED ND:YAG LASER
    Manufacturer
    HOYA PHOTONICS, INC.
    Date Cleared
    2005-06-17

    (91 days)

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

    HOYA PHOTONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Treatment of Pigmented Lesions Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
    Device Description
    Not Found
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    K Number
    K050274
    Device Name
    DIODENT II DENTAL LASER SYSTEM
    Manufacturer
    HOYA PHOTONICS, INC.
    Date Cleared
    2005-04-29

    (81 days)

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

    HOYA PHOTONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue. Examples: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Sucular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) Treatment of aphthous ulcers Vestibuloplasty Biopsy incision and excision Lesion (tumor) removal For light activation for bleaching materials for teeth whitening For laser-assisted bleaching/whitening for teeth.
    Device Description
    Not Found
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    K Number
    K041721
    Device Name
    LVI AESTHETIC LASER
    Manufacturer
    HOYA PHOTONICS, INC.
    Date Cleared
    2004-08-05

    (42 days)

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

    HOYA PHOTONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For the incision, excision, ablation, vaporization, and hemostasis of oral soft tissue. Examples: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy and frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis Implant recovery Incision and drainage of abscess Leukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Sulcular debridement (removal of diseased or inflamed soft tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) Treatment of aphthous ulcers Vestibuloplasty Biopsy incision and excision Lesion (tumor) removal For light activation for bleaching materials for teeth whitening For laser-assisted bleaching/whitening for teeth.
    Device Description
    Dental diode laser
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    K Number
    K032797
    Device Name
    DELIGHT DENTAL ER: YAG LASER SYSTEM
    Manufacturer
    HOYA PHOTONICS, INC.
    Date Cleared
    2004-04-05

    (210 days)

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

    HOYA PHOTONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cutting, shaving, contouring and resection of oral osseous tissues (bone).
    Device Description
    Not Found
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