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510(k) Data Aggregation

    K Number
    K241601
    Device Name
    EMS (FlexPulse, MagnaCore, Magnetika)
    Date Cleared
    2025-02-25

    (266 days)

    Product Code
    Regulation Number
    890.5850
    Why did this record match?
    Applicant Name (Manufacturer) :

    CPMT LASER (Canadian Pioneer Medical Technology Corporation)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is indicated to be used for: · Improvement of abdominal tone, strengthening of the abdominal muscles, development of firmer abdomen. - · Strengthening, Toning and Firming of buttocks and thigh
    Device Description
    The Electromagnetic Stimulator Device, with models FlexPulse, MagnaCore, and MagnetiKa, consists of a main unit, handpiece tools, and a power cable. The main unit has a power supply unit, a control unit, and a cooling unit. The control unit has a control element and a liquid crystal display. The handpiece tools have electromagnetic induction coils and cooling fans, it is a non-invasive device. The device generates an electromagnetic field that interacts with human body tissues, aiding in muscle stimulation to strengthen and tone the abdomen, buttocks, and thighs. With two outputs, it allows simultaneous treatment using two applicators.
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    K Number
    K232133
    Device Name
    Co2 Laser System, Models: PureLase And VanLase
    Date Cleared
    2024-04-16

    (273 days)

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

    CPMT Laser (Canadian Pioneer Medical Technology Corporation)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    CO2 Laser System is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiaty, otolaryngology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), dental and oral surgery and genitourinary surgery. The use with the scanning unit is indicated for ablative skin resurfacing.
    Device Description
    The CO2 Laser System is a computer controlled radiofrequency (RF) excited carbon dioxide (CO2) laser system that delivers CO2 energy to the target treatment area at 10,600 nm. The CO2 Laser System is comprised of multiple components, including the control unit and handpieces. Laser is transmitted to the tissue via a series of lenses integrated into the articulated arm. The CO2 laser energy is absorbed by water in tissue to achieve its intended treatment effects.
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    K Number
    K222673
    Device Name
    Alexandrite and Nd:YAG Laser models CANLASE and TORLASE
    Date Cleared
    2022-11-17

    (72 days)

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

    Canadian Pioneer Medical Technology Corporation (CPMT LASER)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    755mm: Temporary hair reduction. Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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. On all skin types (Fitzpatrick I-VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). 1064nm: Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment 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. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented lesion size. for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. Temporary increase of clear nail in patients with onychomycosis ( e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)
    Device Description
    Alexandrite Nd:YAG laser Models CPMT CANLASE , CPMT TORLASE contain two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system. This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat.
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    K Number
    K222915
    Device Name
    Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS
    Date Cleared
    2022-11-15

    (50 days)

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

    Canadian Pioneer Medical Technology Corporation (CPMT LASER)

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The device is intended for use in dermatologic and general surgical procedures. The simultaneous triple wavelength handpiece is intended for use in dermatology procedures requiring coagulation. The indications for use for the Triple wavelength handpiece include: Benign vascular and vascular dependent lesions removal. The indications for use for the handpiece of 1064nm include: - -The Hair Removal is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. - Treatment of Pseudo folliculitis Barbae (PFB) - - Use on all skin types (Fitzpatrick I-VI), including tanned skin. - The indications for use for the handpiece of 808 nm include: - -The Hair Removal (HR) is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. - The treatment of benign vascular and pigmented lesions. - - -Use on all skin types (Fitzpatrick I-VI), including tanned skin. The indications for use for the handpiece of 755 nm include: - The Hair Removal (HR) is intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6,9 and 12 months after the completion of a treatment regimen. - The treatment of benign vascular and pigmented lesions. - - -Use on all skin types (Fitzpatrick I-VI), including tanned skin.
    Device Description
    The Quadruple Laser System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit. The Laser treatment device is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective photothermolysis. The wavelength of 808nm, 755, and 1064nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system. The proposed device includes power supply system, control system, control system, cooling system, laser system. The 755nm, 808 nm, 1064nm handpieces with different treatment sizes are available for different models.
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    K Number
    K211722
    Device Name
    Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
    Date Cleared
    2022-02-25

    (266 days)

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

    Canadian Pioneer Medical Technology Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for : · Benign vascular lesions and vascular dependent lesions removal
    Device Description
    The Laser Treatment System consists of the main unit and its handpieces. The system uses laser as an active medium placed in an optical cavity to produce amplified beam at the applicators and the Simultaneous triple-wavelength of 755,808 and 1064 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit. The Laser Treatment System is designed to be used dermatology procedures requiring coagulation. The indications for use for the 3 simultaneously wavelength 755,808,1064 nm Laser Module is treatment of benign vascular and vascular dependent lesions.
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    K Number
    K212793
    Device Name
    Laser Treatment System, Model: Hera, Armo
    Date Cleared
    2021-10-25

    (54 days)

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

    Canadian Pioneer Medical Technology Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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 Laser Treatment System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam at the wavelength of 808 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit. The Diode Laser Therapy Devices is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective photothermolysis. The wavelength of 808nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system. The proposed device includes power supply system, delivery system, control system, cooling system, laser system. The models object of this submission are Armo and Hera: Hera has one handpiece connector. Armo has two handpiece connectors. The 808 nm handpieces with different spot sizes (3 spot sizes : 12×12mm,12×20mm,15×27m) are available for both models.
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    K Number
    K210033
    Device Name
    Laser Treatment System, Model: NYX and Grace
    Date Cleared
    2021-02-26

    (52 days)

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

    Canadian Pioneer Medical Technology Corporation

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. 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 Laser Treatment System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam at the wavelength of 808 nm. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit. The diode laser operates in a pulsed mode with a fixed pulse width and fixed pulse duration of the pulse train for each mode. The number of pulses can be adjusted within the preset range. The Laser Treatment System includes two (2) models, NYX and Grace, the differences between them are the external shape and the numbers of the handpiece connectors, NYX is the desktop type with one handpiece connector, and Grace is vertical stand type with two handpiece connectors.
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