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510(k) Data Aggregation

    K Number
    K022709
    Device Name
    MEDLITE Q-SWITHCED LASER
    Manufacturer
    CONTINUUM ELECTRO-OPTICS, INC.
    Date Cleared
    2003-02-20

    (190 days)

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

    CONTINUUM ELECTRO-OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Medlite Q-Switched Laser System is indicated for use in dermatologic and general surgical procedures for coagulation and hemostasis. The Medlite Q-Switched Laser System is indicated for use in laser skin resurfacing procedures for the treatment of acne scars and wrinkles.
    Device Description
    The Medlite Q-Switched Laser is a laser device with a Nd:YAG laser medium, Q-Switched pulse method, Max Power of 30 Watts, Wavelength of 1064 & 532, Power Supply of 110/120 VAC - 50/60 Hz and 220/240 VAC - 50/60 Hz, Pulse Rate of 1, 2, 5, 10, Single Shot, Pulse Duration (nsec) of Less than 20, Beam Delivery via Handpiece using articulated arm, Multimode Beam Quality, and Microprocessor Control.
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    K Number
    K022351
    Device Name
    DIODENT DENTAL LASER SYSTEM
    Manufacturer
    CONTINUUM ELECTRO-OPTICS, INC.
    Date Cleared
    2002-10-16

    (89 days)

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

    CONTINUUM ELECTRO-OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Light activation for bleaching materials for teeth whitening. Laser-assisted bleaching/whitening for teeth.
    Device Description
    Not Found
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    K Number
    K021616
    Device Name
    DELIGHT DENTAL ER: YAG LASER SYSTEM
    Manufacturer
    CONTINUUM ELECTRO-OPTICS, INC.
    Date Cleared
    2002-07-11

    (56 days)

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

    CONTINUUM ELECTRO-OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Tooth preparation to obtain access to the root canal - Pulpotomy - Pulp extirpation - Pulpotomy as an adjunct to root canal therapy - Root canal debridement and cleaning - Root canal preparation including enlargement
    Device Description
    Not Found
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    K Number
    K013216
    Device Name
    DIODENT DENTAL LASER SYSTEM
    Manufacturer
    CONTINUUM ELECTRO-OPTICS, INC.
    Date Cleared
    2002-02-27

    (154 days)

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

    CONTINUUM ELECTRO-OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DioDent Dental Laser System is intended for incision, excision, ablation, vaporization and/or coagulation of oral soft tissue (including marginal and interdental gingiva and epithelial lining of free gingiva). 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 adjunt 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
    Device Description
    Not Found
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    K Number
    K014234
    Device Name
    MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER
    Manufacturer
    CONTINUUM ELECTRO-OPTICS, INC.
    Date Cleared
    2002-01-17

    (22 days)

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

    CONTINUUM ELECTRO-OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Tattoo Removal - dark ink: blue and black - light ink: red - light ink: sky blue - light ink: green Treatment of Vascular Lesions - port wine birthmarks - telangiectasias - spider angioma - cherry angioma - spider nevi Treatment of Pigmented Lesions - cafe-au-lait birthmarks - solar lentiginos - senile lentiginos - becker's nevi - freckles - nevus spilus - nevus of ota Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology Removal or lightening of unwanted hair with or without adjuvant preparation
    Device Description
    Medlite C6 Q-Switched Nd:YAG Laser
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    K Number
    K011677
    Device Name
    MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER
    Manufacturer
    CONTINUUM ELECTRO-OPTICS, INC.
    Date Cleared
    2001-06-22

    (23 days)

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

    CONTINUUM ELECTRO-OPTICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    • Tattoo Removal • Treatment of Vascular Lesions • Treatment of Pigmented Lesions • Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
    Device Description
    The MedliteTM C3 Q-Switched Nd:YAG Laser bases its design/construction from the integration of primary subsystems extracted from legally marketed predicate Continuum products. The new device performs and is specified within all product parameters of the predicate devices.
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