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510(k) Data Aggregation

    K Number
    K083899
    Device Name
    REVLITE Q-SWITCHED ND:YAG LASER SYSTEM
    Manufacturer
    HOYA CONBIO, INC
    Date Cleared
    2009-06-01

    (154 days)

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

    HOYA CONBIO, 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) - 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 entire laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of an articulated arm and a specially designed MultiSpot Handpiece (532 nm and 1064 nm) or optional Multilite Dye Laser Handpiece (650 nm and 585 nm). The user activates laser emission by means of a footswitch. The RevLite Systems are designed to provide laser energy for use in a variety of dermatological procedures (see indications for use). The 532 nm and 1064 nm wavelengths and optional 650 nm and 585 nm wavelengths are absorbed by pigment and other chromophores within the skin to create the desired clinical effect. The laser incorporates very narrow laser pulses (5-20 ns) designed to apply higher peak power over a very short period to minimize the time to absorb heat into the tissue.
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    K Number
    K073158
    Device Name
    SCULPTURE 2.94 ER:YAG SYSTEM
    Manufacturer
    HOYA CONBIO, INC
    Date Cleared
    2008-08-27

    (293 days)

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

    HOYA CONBIO, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DERMASCULPT is intended for Dermatological procedures requiring incision, excision, coagulation and vaporization of soft tissue. The specific indications using the applicable handpieces are as follows: Skin resurfacing in the treatment of wrinkles and scar revision (including acne scars) with the non-fractionated handpiece. Removal of cutaneous skin lesions with the micron tip handpieces including epidermal nevi, actinic chellitis, keloids, verrucae, skin tags, anal tags, keratosis, scar revision, (including acne scars), benign tumors and cysts, superficial skin lesions and diagnostic biopsies. The DERMASCULPT with the fractionated scanner handpiece is intended/indicated for Dermatological procedures requiring coagulation of soft tissue and skin resurfacing.
    Device Description
    The DermaSCULPT Er:YAG Laser System [DermaSCULPT] unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. The laser energy produced within the device is delivered to the tissue by means of Fiber Delivery System and specially designed Scanner, Handpieces, Tips and Adaptors. The user activates laser emission by means of a footswitch. The lamp power supply causes the flash lamp to light, causing the emission of an invisible infrared Er:YAG laser beam (2.94 microns). A visible white light pulsed beam from the flashlamp is used as an aiming beam. The laser beam passes through a partially reflecting mirror and then passes through the energy monitor, after which its power is measured. When all the pre-conditions have been satisfied and the READY button is pressed and the foot switch is depressed, the safety shutter opens and the laser beam is allowed into the delivery unit coupler. The electrical system is comprised of the laser power supply, the control unit, calibrator, control panel, key switch, emergency stop switch, and foot switch. The components of the laser power supply include a high voltage power supply and a high voltage trigger control board. The high voltage power supply uses the high voltage to illuminate the flashlamp. The control unit comprises a microprocessor board, accessory board and other components that it controls. The calibrator measures the transmittance of the fiber delivery unit. The handheld scanner module is an attachment to the fiber.
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    K Number
    K073332
    Device Name
    V-RASER DIODE LASER SYSTEM
    Manufacturer
    HOYA CONBIO, INC
    Date Cleared
    2008-02-14

    (79 days)

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

    HOYA CONBIO, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Use:The V-Raser is intended for Incision, excision, ablation, vaporization and coagulation of soft tissue. Specific Indications: Treatment of vascular lesions.
    Device Description
    The V-RASER Diode System is a modified Diodent Micro 980. It will use similar specifications (laser medium, excitation method, fiber optic beam delivery, electrical requirements, physical specifications) as the Diodent Micro 980. The laser source of this device is a solid-state Gallium Aluminum Arsenide (GaAlAs) semiconductor diode. It produces invisible laser energy at the 980-nanometer wavelength. The delivery system consists of removable flexible HCS (hard clad silica) optical treatment fiber assembly connected to a lightweight, hand piece that has two different size end pieces (tips) to adjust the laser beam to specific spot sizes. Activation occurs when the operator enables the laser by a key switch, enters the Ready Mode and presses the footswitch. Releasing the footswitch suspends laser treatment. A color LCD and touch-screen display panel allows the operator to adjust or set the laser output level. The laser operates in a pulsed mode and will have a removable stainless steel end piece for establishing the proper focal length for the treatment. The hand piece will be manually attached (i.e., screwed on) to a connector to the fiber assembly. The spot size will be selected on the control panel and the software will calculate the treatment fluence accordingly.
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    K Number
    K063384
    Device Name
    DIODENT MICRO DENTAL LASER SYSTEM, MODELS 810 AND 980
    Manufacturer
    HOYA CONBIO, INC
    Date Cleared
    2007-03-16

    (128 days)

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

    HOYA CONBIO, 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 Reduction of bacterial level (decontamination) and inflammation 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
    The laser source of the DioDent Micro 810/980 is a solid-state Gallium Aluminum Arsenide (GaAlAs) semiconductor diode. It produces invisible laser energy at the 810-nanometer or 980nm wavelength. The delivery system consists of an autoclavable flexible treatment fiber threaded through a lightweight, autoclavable hand piece. Activation occurs when the operator enables the laser and presses the footswitch. Releasing the footswitch suspends laser treatment. The footswitch can function as an on/off switch. A color touch-screen display panel allows the operator to adjust or set laser output level with minimal effort. The laser can operate in continuous wave or pulse mode.
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    K Number
    K063834
    Device Name
    REVLITE C6 Q-SWITCHED ND:YAG LASER SYSTEM
    Manufacturer
    HOYA CONBIO, INC
    Date Cleared
    2007-01-25

    (30 days)

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

    HOYA CONBIO, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RevLite O-switched Nd: YAG Laser System is indicated for 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: (Black & Blue) Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation. Skin resurfacing procedures for the treatment of acne scars and wrinkles 532 nm wavelength (nominal delivered energy of 585nm and 650 nm with the Optional Multilite Dye Laser Handpiece): Tattoo Removal: Light Ink (Red, Sky Blue, Green) Treatment of Vascular Lesions including, but not limited to: - . Prot wine birthmarks - Telangiectasias . - Spider angioma . - Cherry angioma . - Spider nevi . Treatment of Pigmented Lesions including, but not limited to: - Café-au-lait bithmarks . - Solar lentiginos . - Senile lentiginos . - Becker's nevi . - Freckles . - Nevus spilus . Skin resurfacing procedures for the treatment of acne scars and wrinkles.
    Device Description
    The RevLite System with LCD Panel laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of an articulated arm and a specially designed MultiSpot Handpiece or optional Multilite Dye Laser Handpieces. The user activates laser emission by means of a footswitch. The RevLite System incorporates 2 very narrow laser applications designed to apply more energy over a larger spot size at the same fluence level, enabling the physician to treat a larger area more rapidly.
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    K Number
    K063112
    Device Name
    REVLITE Q-SWITCHED ND:YAG LASER
    Manufacturer
    HOYA CONBIO, INC
    Date Cleared
    2006-12-01

    (51 days)

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

    HOYA CONBIO, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RevLite Q-Switched Nd: YAG Laser System is indicated for Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology, Dermatology, Dermand General Surgical Procedures for Coagulation and Hemostasis. Specific Indications: 1064 nm wavelength: Tattoo Removal: Dark Ink: (Black & Blue) Nevus of Ota Removal or lightening of unwanted hair with or without adjuvant preparation. Skin resurfacing procedures for the treatment of acne scars and wrinkles 532 nm wavelength (nominal delivered energy of 585nm and 650 nm with the Optional Multilite Dye Laser Handpiece): Tattoo Removal: Light Ink (Red, Sky Blue, Green) Treatment of Vascular Lesions including, but not limited to: - port wine birthmarks - . telangiectasias - spidcr angioma - . cherry angioma - spider nevi Treatment of Pigmented Lesions including, but not limited to: - . cafe-au-lait birthmarks - . solar lentiginos - . senile lentiginos - Becker's nevi - Freckles - Nevus spilus ◆ Skin resurfacing procedures for the treatment of acne scars and wrinkles
    Device Description
    The RevLite System laser unit and controls are contained in a single console. Electrical power is supplied to the console by the facility's power source. Laser energy produced within the device is delivered to the tissue by means of an articulated arm and a specially designed MultiSpot Handpiece or optional Multilite Dye Laser Handpieces. The user activates laser emission by means of a footswitch. The RevLite System incorporates 2 very narrow laser applications designed to apply more energy over a larger spot size at the same fluence level, enabling the physician to treat a larger area more rapidly.
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    K Number
    K060977
    Device Name
    MEDLITE C SERIES COMPRESSION TOOL AND HANDPIECE ATTACHMENT ACCESSORY, MODEL 659-0523
    Manufacturer
    HOYA CONBIO, INC
    Date Cleared
    2006-05-24

    (44 days)

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

    HOYA CONBIO, INC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For use in dermatology for all currently approved indications for the Medlite C-Series Nd: YAG Laser Systems and MultiSpot Handpiece. Tattoo Removal Nevus of Ota Hair Removal Vascular Lesions Dermal Pigmented Lesions Epidermal Pigmented Lesions Laser Resurfacing for Acne scars and wrinkles Incision, Excision, Ablation, Vaporization of Soft Tissue for General Dermatology
    Device Description
    The Compression Tool and Handpiece Attachment Accessories are intended to be used to assist and enhance the procedure of treating dermatological conditions The Compression Tool and Handpiece Attachment Accessories are additional accessories designed to accompany the currently offered MedLite MultiSpot Handpiece. The purpose for these accessories are purely for a cosmetic end to help reduce undesirable purpura while treating with the Medlite C Series lasers.
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