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510(k) Data Aggregation

    K Number
    K172714
    Device Name
    LipiVage
    Manufacturer
    Genesis Biosystems, Inc.
    Date Cleared
    2017-12-08

    (91 days)

    Product Code
    MUU, 878
    Regulation Number
    878.5040
    Why did this record match?
    Applicant Name (Manufacturer) :

    Genesis Biosystems, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LipiVage® is used for aspiration, harvesting, filtering, and transferring of autologous adipose tissue for aesthetic body contouring. The system should be used with a legally marketed vacuum or aspirator apparatus as a source of suction. If harvested fat is to be re-implanted, the harvested fat is only to be used without any additional manipulation. LipiVage® is intended for use in the following surgical specialties when aspiration of soft tissue is desired: plastic and reconstructive surgery, neurosurgery, gastrointestinal and affiliated organ surgery, urological surgery, general surgery, orthopedic surgery, gynecological surgery, thoracic surgery, and laparoscopic surgery.
    Device Description
    LipiVage® is a 60cc hollow barrel harvesting syringe with plunger and an in-line polyester filter that is intended to receive, concentrate and filter autologous adipose tissue from lipoplasty procedures, for reimplantation of the extracted tissue back into the same patient at other anatomical locations in their body using a piston syringe and injection cannula. At one end of the LipiVage® harvesting syringe there is a male connector (nozzle) for fitting the female connector (hub) of a cannula for the harvesting of fat cells, while at the other end of the device there is a universal tubing connection to attach to a tubing set (not supplied by Genesis) that is connected to a controlled vacuum source, such as an aspirator or wall suction in the user facility. The LipiVage® harvesting syringe incorporates an in-line filter so there is no need to centrifuge, decant or expose fat cells to unnecessary handling. The device is for professional use only, made from medical grade polymers, single use, and provided sterile to the user.
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    K Number
    K131142
    Device Name
    GENESIS LED WANDS
    Manufacturer
    GENESIS BIOSYSTEMS, INC.
    Date Cleared
    2013-11-27

    (218 days)

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

    GENESIS BIOSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Red: Generally indicated for use in dermatology for the treatment of superficial, benign vascular and pigmented legions. Blue: Generally indicated to treat dermatological conditions and specifically indicated to treat moderate inflammatory acne vulgaris.
    Device Description
    The Genesis LED Device uses high-end Light Emitting Diodes (LED's) to distribute the specific wavelengths of light it uses. This technology is commonly referred to as Photobiostimulation, Light Emitting Diode Therapy (LEDT), or LED's. The application of LED's to tissue is non-invasive. The Genesis LED Wands emit light at the following wavelengths: Genesis LED Wand RED at 627 nm and Genesis LED Wand BLUE at 415 nm.
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    K Number
    K082484
    Device Name
    ACCELAWAVE SYSTEM
    Manufacturer
    GENESIS BIOSYSTEMS, INC.
    Date Cleared
    2008-09-12

    (15 days)

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

    GENESIS BIOSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for Use for Fitzpatrick skin types (I to VI) - The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen. - The treatment of moderate inflammatory acne vulgaris. - The treatment of benign pigmented epidermal lesions including dyschromia. hyperpigmentation, melasma, ephelides (freckles) - The treatment of cutaneous lesions including warts, scars, and striae. - The treatment of benign cutaneous vascular lesions, including port wine stains. hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations. The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after treatment in general aesthetic dermatologic and plastic surgery procedures. - Reduce pain during and/or with light treatment (via partial anesthesia from cooling) - Reduce discomfort during and/or associated with light treatment - Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypopigmentation - Allow the use of higher light fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions) - Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
    Device Description
    The Accelawave is an Intense Pulsed Light-based medical device utilizing xenon flash lamp technology to illuminate the dermis to offer light based therapies as listed in the indications of use. The Accelawave emits light at 420nm to 1200nm via a 15mm x 45mm treatment area at a repetition rate equal to or less than 0.5Hz (operator selective). Light is delivered to the skin surface while a water-cooled heat transfer network cools the contacting surfaces and the epidermis.
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    K Number
    K081578
    Device Name
    ACCELA SYSTEM
    Manufacturer
    GENESIS BIOSYSTEMS, INC.
    Date Cleared
    2008-06-20

    (15 days)

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

    GENESIS BIOSYSTEMS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Indications for Use for Fitzpatrick skin types (I to VI) - The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent hair reduction is defined as a long-term stable reduction in the number of hairs re-growing after a treatment regimen. - The treatment of moderate inflammatory acne vulgaris - The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, ephelides (freckles) - The treatment of cutaneous lesions including warts, scars, and striae. - The treatment of benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, erythema of rosacea, angiomas, and spider angiomas, poikiloderma of civatte, leg veins and venous malformations. The integrated thermal cooling is indicated for use in cooling the epidermis at the treatment site prior to, during, and after light or laser treatment in general aesthetic dermatologic and plastic surgery procedures. - Reduce pain during and/or with light or laser treatment (via partial anesthesia from cooling) - Reduce discomfort during and/or associated with light or laser treatment - Minimize thermal injury, including thermal necrosis, to non-target skin and skin structures during and/or associated with light or laser treatment, thus reducing possible complications such as scabbing, scarring, hyper - and/or hypopigmentation - Allow the use of higher light or laser fluences for light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions) - Reduce potential side effects of light or laser treatments (such as for hair removal and the treatment of vascular or pigmented lesions)
    Device Description
    The Accela is an Intense Pulsed Light-based medical device utilizing xenon flash lamp technology to illuminate the dermis to offer light based therapies as listed in the indications of use. The Accela emits light at 400nm to 1200nm via a 50mm x 50mm treatment area at a repetition rate equal to or less than 0.5Hz (operator selective). Light is delivered to the skin surface, while cold air integrated through the handpiece, is provided to cool the epidermis.
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