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510(k) Data Aggregation

    K Number
    K183307
    Device Name
    Magma Spark Pro (Magma Spark Plus, Alpha)
    Manufacturer
    Formatk Systems Ltd.
    Date Cleared
    2018-12-11

    (13 days)

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

    Formatk Systems Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Magma Spark Pro system intended use is for non-invasive aesthetic and cosmetic treatments. The Magma Spark Pro system has connection capability with the following available treatment hand pieces, for multiapplication treatment options. All hand pieces are designed for aesthetic and dermatological skin procedure applications, as follows: · Magma Spark Pro system with ALD/LLD Laser hand piece is indicated for: o Hair removal - o Permanent hair reduction * in skin type I-VI o Pseudofolliculitis Barbae (PFB) · Magma Spark Pro system with Intense Pulsed Light (IPL) Hand pieces (5 different Applicators) with a spectrum of 430-1100nm is intended for: o Magma Spark Pro system with L-650 (650-1100nm) IPL hand piece is indicated for: " Removal of unwanted hair from all skin types, and to effect stable long term. or permanent hair reduction * in skin types I-V through selective targeting of melanin in hair follicles. " Benign epidermal lesions, including dyschromia, hyperpigmentation o Magma Spark Pro system with S-590 (590-1100nm) IPL hand piece is indicated for: ▪ Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair recuction * in skin types I-IV through selective targeting of melanin in hair follicles. · Benign epidermal lesions, including dyschromia, hyperpigmentation, melasma and ephelides (freckles) · 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, venous malformations. o Magma Spark Pro system with L-530 (530-1100nm) IPL hand piece is indicated for: · Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles) - · Cutaneous lesions, including warts, scars and striae · 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. o Magma Spark Pro system with S-530 (530-1100nm) IPL hand piece is indicated for: · Mild to moderate inflammatory Acne (Acne vulgaris) · Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles) - · Cutaneous lesions, including warts, scars and striae · 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 o Magma Spark Pro system with S-430 (430-1100nm) IPL hand piece is indicated for: = Mild to moderate inflammatory Acne (Acne vulgaris) Note * Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
    Device Description
    The Magma Spark Pro device is a computerized, multi-application, compatible system platform designed to provide laser and intense pulsed light (IPL) optical energies for noninvasive aesthetic dermatology procedures. The Magma Spark Pro is a relatively small tabletop device (portable version is also available). The device is compatible with two diode laser applicators (ALD and LLD) at nominal 808 nm wavelength and five IPL applicators: S-430, S-530, S-590, L-530 and L-650 at a wavelength range of 430-1100 nm. The system platform includes an AC/DC safety approved power supply, a CPU board, a Laser driver board, a charging board, a simmer board, an LCD display, Wires connectors and control components (inlet with On/Off switch and fuses, Emergency button), footswitch panel, water based cooling system for IPL and Laser applicators cooling and a touch screen module. The operator of Magma Spark Pro chooses and monitors the mode and intensity of the treatment from a digital control panel on the front of the device. Melanin meter is provided as an accessory tool for skin type determination.
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    K Number
    K162781
    Device Name
    Magma Spark
    Manufacturer
    Formatk Systems Ltd.
    Date Cleared
    2016-11-09

    (37 days)

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

    Formatk Systems Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Magma Spark device is indicated for use in aesthetic applications in dermatology. Magma Spark device has connection capability with the follo\ving available treatment hand-pieces (applicators), for multiapplication treatment options. All hand-pieces are designed for aesthetic demlatologic procedure applications. Magma Spark device \vith ALD or LLD diode laser applicators is indicated for hair removal, pennanent hair reduction* in skin types I-VI and for the treatment of pseudofolliculitis barbae (PFB). (*Permanent hair reduction is defined as long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after completion of treatment regime)
    Device Description
    The Magma Spark device is a computerized multi-application platform intended for non-invasive aesthetic applications utilizing laser optical power. Magma Spark is a relatively small tabletop device that provided with melanin meter and two diode laser applicators (ALD and LLD) at nominal 808 nm wavelength. The system platform includes AC/DC power supply unit, water based cooling system, CPU main card and user interface including an LCD display and touch screen module. The operator of Magma Spark chooses and monitors the mode and intensity of the treatment from a digital control panel on the front of the device.
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    K Number
    K160195
    Device Name
    Forma System, Forma Light System
    Manufacturer
    FORMATK SYSTEMS LTD.
    Date Cleared
    2016-04-15

    (79 days)

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

    FORMATK SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Forma System and Forma Light System** are indicated for use in aesthetic applications in dermatology. The Forma System and Forma Light System** have connection capability with the following available treatment handpieces, for multi application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows: 1) The Forma System and Forma Light System** with the Intense Pulsed Light (IPL) Handpieces (10 different Applicators) with a spectrum of 430-1100nm are indicated for: HR*, F-HR*, B-HR* Applicators (650-1100nm): · Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types I-V through selective targeting of melanin in hair follicles. HR, F-HR, B-HR Applicators (590-1100nm): · Removal of unwanted hair from skin types I-IV, and to effect stable long term, or permanent hair reduction* in skin types I-IV through selective targeting of melanin in hair follicles. SR, F-SR, B-SR Applicators (530-1100nm): - · Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles) - · Cutaneous lesions, including striae · 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. F-AC Applicator (430-1100nm): · Mild to moderate inflammatory Acne (Acne vulgaris) 2) The Forma System with the ST Handpiece (Radio Frequency) is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. 3) The Forma System with the PLG Handpiece (Microdermabrasion Applicator) is indicated for skin dermabrasion.
    Device Description
    The Forma System is a multi-application, multi-technology platform, intended for noninvasive aesthetic applications utilizing Radio Frequency (RF) and Intense Pulsed Light (IPL) technologies. The system platform includes an AC/DC power supply unit, an RF Generator, a CPU main card and user interface including a LCD display and touch screen module. In addition to the system platform, the Forma System is provided with 12 applicators according to the following technology related sub-categories: - . ST Applicator (Radiofrequency) for the treatment of relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation. - Ten Intense Pulsed Light (IPL) Applicators divided into four sub-categories: o - o HR*, F-HR* & B-HR* (650-1100nm) Applicators for hair removal treatments (skin types I-V). - HR, F-HR & B-HR (590-1100nm) Applicators for hair removal o treatments (skin types I-IV). - o SR, F-SR & B-SR (530-1100nm) Applicators for the treatment of pigmented and vascular lesions. - o F-AC (430-1100nm) Applicator for acne treatments. - PLG Applicator (Diamond ring) is indicated for skin dermabrasion. ● The operator chooses and monitors the mode and intensity of the treatment from a digital control panel located on the front panel of the Forma System. The Forma System has three applicator ports; one for IPL based applicators, one for RF applicator and one for the skin dermabrasion applicator. The ports must be simultaneously connected with all there applicators for the system to operate. The Forma Light System is a model of the Forma System employing only IPL technology.
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    K Number
    K153566
    Device Name
    Magma System
    Manufacturer
    FORMATK SYSTEMS LTD.
    Date Cleared
    2016-04-06

    (114 days)

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

    FORMATK SYSTEMS LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Magma System is indicated for use in aesthetic applications in dermatology. The Magma System has connection capability with the following available treatment handpieces, for multi application treatment options. All handpieces are designed for aesthetic and dermatological skin procedure applications, as follows: 1. The Magma System with ALD/LLD Laser Handpiece is indicated for hair removal, permanent hair reduction* in skin types I-VI and for the treatment of Pseudofolliculitis Barbae (PFB). 2. The Magma System with Nd: Y AG Laser Handpiece (ND) with a wavelength of 1064 nm (Multi-Spot Nd: Y AG) is indicated for: · The coagulation and hemostasis of vascular lesions and soft tissue, including the treatment of superficial and deep telangiectasias (venulectasias) and reticular veins (0.1 - 4.0 mm. diameter) of the leg · The removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction® in skin types I-V through selective targeting of melanin in hair follicles. • The non-ablative treatment of facial wrinkles 3. The Magma System with the Intense Pulsed Light (IPL) Handpieces (10 different Applicators) with a spectrum of 430-1100nm is indicated for: HR*, F-HR*, B-HR* Applicators (650-1100nm): · Removal of unwanted hair from all skin types, and to effect stable long term, or permanent hair reduction* in skin types I-V through selective targeting of melanin in hair follicles. HR, F-HR, B-HR Applicators (590-1100nm): • Removal of unwanted hair from skin types I-IV, and to effect stable long term, or permanent hair reduction* in skin types I-IV through selective targeting of melanin in hair follicles. SR, F-SR, B-SR Applicators (530-1100nm): · Benign epidermal lesions, including dyschromia, hyperpigmentation, ephelides (freckles) · Cutaneous lesions, including striae · 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. F-AC Applicator (430-1100nm): T-AC Applicator (+50-1100mm). · Mild to moderate inflammatory Acne (Acne vulgaris) *Note Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
    Device Description
    The Magma System is a computerized multi-application, multi-technology platform, intended for non-invasive aesthetic applications utilizing laser and Intense Pulsed Light (IPL) optical power. The system platform includes AC/DC power supply unit, water based cooling system, CPU main card and user interface including a LCD display and touch screen module. Apart from the system platform the Magma System is provided with 13 applicators divided into three technology related sub-categories: - ALD & LLD Diode laser (808nm) Applicators for hair removal treatments. - Multi-spot Nd:YAG laser (1064nm) Applicator for coagulation and hemostasis of vascular lesions and soft tissue, hair removal treatments and non-ablative treatment of facial wrinkles. - Ten Intense Pulsed Light (IPL) Applicators divided into four sub-categories: - o HR*, F-HR* & B-HR* (650-1100nm) Applicators for hair removal treatments (skin types I-V). - o HR, F-HR & B-HR (590-1100nm) Applicators for hair removal treatments (skin types I-IV). - o SR. F-SR & B-SR (530-1100mm) Applicators for the treatment of pigmented and vascular lesions. - o F-AC (430-1100nm) Applicator for acne treatments. The operator chooses and monitors the mode and intensity of the treatment from a digital control panel on the front of the Magma System. The Magma System has two applicator ports; one for IPL based applicators and one for Laser applicators. The ports must be simultaneously connected with both laser and IPL applicators for the system to operate.
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