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510(k) Data Aggregation

    K Number
    K161502
    Device Name
    MC1 Plus
    Manufacturer
    GENERAL PROJECT S.R.L.
    Date Cleared
    2016-08-16

    (76 days)

    Product Code
    IMI
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENERAL PROJECT S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MC1 Plus is indicated for: a) Therapeutic Massager: 1. Provides temporary relief of minor muscle aches and pains; 2. Relieves muscle spasms; 3. Temporarily improves local blood circulation; 4. Temporarily reduces the appearance of cellulite. b) Ultrasonic Diathermy: 1. Relief of pain; 2. Muscle spasms; 3. Joint contractures; 4. NOT for the treatment of malignancies.
    Device Description
    MC1 Plus is a computerized body massager and ultrasound diathermy system. The MC1 Plus is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massager.
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    K Number
    K091615
    Device Name
    MED CONTOUR
    Manufacturer
    GENERAL PROJECT S.R.L.
    Date Cleared
    2010-05-06

    (337 days)

    Product Code
    IMI, ISA
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENERAL PROJECT S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MC1 is indicated for: a) Therapeutic Massager: 1. Provides temporary relief of minor muscle aches and pains; 2. Relieves muscle spasms, 3. Temporarily improves local blood circulation; 4. Temporarily reduces the appearance of cellulite. b) Ultrasonic Diathermy: 1. Relief of pain; 2. Muscle spasms; 3. Joint contractures; 4. NOT for the treatment of malignancies.
    Device Description
    The MC1 is a computerized body massager and ultrasound diathermy system. The MC1 is supplied with two handpieces: one ultrasonic handpiece with two 1 MHz transducers mounted on it and one handpiece for computerized body massage.
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    K Number
    K062312
    Device Name
    AXIOM PULSED LIGHT SYSTEM
    Manufacturer
    GENERAL PROJECT S.R.L.
    Date Cleared
    2006-10-16

    (69 days)

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

    GENERAL PROJECT S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. It is intended for use in: - Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction - Treatment of mild to moderate inflammatory acne (acne vulgaris) . - Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and cafè-au-lait
    Device Description
    The Axiom Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 mm to 1200 mm. The Axion Intense Fullood Eight Oyel Cyell is based on a quick power discharge of Capacitors in a Xenon ramp, mountou on a hanspires include the charge intense Fulsed Eight. The four philopal pairol panel, and a handpiece with exchangeable lamp box
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    K Number
    K053041
    Device Name
    MED SCULPT
    Manufacturer
    GENERAL PROJECT S.R.L.
    Date Cleared
    2006-08-02

    (279 days)

    Product Code
    IMI, ISA
    Regulation Number
    890.5300
    Why did this record match?
    Applicant Name (Manufacturer) :

    GENERAL PROJECT S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MED Sculpt Computerized Body Massager and M-Sonic Ultrasound Diathermy is indicated for: a. Therapeutic Massager: i. Provides temporary relief of minor muscle aches and pains . - ii . Relieves muscle spasms iii. Temporarily improves local blood circulation iv. Temporarily reduces the appearance of cellulite b. Ultrasonic Diathermy: i. Relief of pain ii. Muscle spasms III. Joint contractures iv. NOT for the treatment of malignancies
    Device Description
    The MED SCULPT Computerized Body Massager and M-Sonic Ultrasound Diathermy system has massage and ultrasound diathermy components. The massage portion of the device uses a specially designed membrane, made up of elastomeric material. This membrane, fastened onto the handbiece, moves in an alternate way due to changeable depression created by a vacuum pump; such movement is due to the opening and closing of two electronically controlled electrovalves. The unit also includes an ultrasonic handpiece that can be used to perform ultrasound diathermy. Ultrasound is a particular form of mechanical energy which leads to an increase in the molecular vibration of the tissue resulting in heat generation and according to this principle the ultrasonic handpiece of the unit, using an ultrasound wave at the fixed frequency of 3 MHz, produces thermal changes in the areas of the body where it is applied.
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    K Number
    K051508
    Device Name
    MED FLASH II INTENSE PULSED LIGHT SYSTEM.
    Manufacturer
    GENERAL PROJECT S.R.L.
    Date Cleared
    2005-10-05

    (120 days)

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

    GENERAL PROJECT S.R.L.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The MED flash II Intense Pulsed Light System is indicated for use in: - Removal of unwanted hair from all skin types and to effect stable long-term or permanent, hair reduction - Treatment of inflammatory acne (acne vulgaris) - Treatment of benign pigmented epidermal and cutaneous lesions including warts, scars, striae, lentigines, nevi, melasma and café-au-lait - Treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins - The integrated cooling handpiece is intended to provide pre-cooling of the epidermis, to reduce thermal injury to the epidermis, and to reduce patient pain, & discomfort associated with light applications.
    Device Description
    The MED flash II Intense Pulsed Light System is a medical device emitting light radiation in the range from 590 nm to 1200 nm. The system is based on a quick power discharge of capacitors in a Xenon lamp, mounted on a handpiece. This generates a rapid and Intense Pulsed Light. The Med flash II system contains five principal components: - Charge system of the capacitors . - Electronic control system . - Control panel . - Handpiece with exchangeable lamp box ● - Handpiece cooling system .
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