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510(k) Data Aggregation

    K Number
    K212607
    Device Name
    Darwin
    Date Cleared
    2021-11-15

    (90 days)

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

    Luvo Medical Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Diode Laser Handpiece is indicated for: The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as 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. Use on all skin types (Fitzpatrick I-VI) including tanned skin. The IPL Handpiece has various filters to create different wavelengths. The various wavelengths are broken down by wavelength and applicable indication for use: Intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. The IPL handpiece is indicated for: Indication for Use for the 430-980nm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. · For use on Fitzpatrick skin types (I-V) Indication for use for the 515-980mm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, poikiloderma of Civate and Lentigines. • For use on Fitzpatrick skin types (I-V) Indication for use for the 560-980mm wavelength • Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, poikiloderma of Civate and Lentigines. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V) Indication for use for the 585-980mm wavelength • Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types Indication for use for the 640-980mm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V) Indication for use for the 700-980nm wavelength • The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the 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 regime • For use on Fitzpatrick skin types (I-V) RF Microneedling Handpiece The RF MicroNeedling Handpiece is indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis Thermal RF Handpiece The Thermal RF Handpiece is indicated for heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
    Device Description
    The Darwin is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic and aesthetic procedures. The system is comprised of a micro-processor-controlled and userfriendly console that houses the power supply, the electronics and the user interface. It has 4 handpieces that are attached to the console, which can be selected for use in treatment through the user interface. There are 4 separate handpieces. Each handpiece has its own indication for use. - . Diode Laser Handpiece - IPL Handpiece - RF Microneedling Handpiece . - Thermal RF The Diode Laser handpiece uses laser light in the 808nm wavelength for hair removal. The laser removes hair, employing a method knows as selective photothermolysis. This involves raising the temperature of the hair follicle without damaging the epidermis and the surrounding tissue. Delivering pulsed light using a coherent light source of 808nm wavelength, the diode laser handpiece is intended for hair removal and permanent hair reduction on skin types (Fitzpatrick skin types I - V). The user can choose from two modes: hair removal shot (HRS) and hair removal moving (HRM) when using the Diode laser handpiece. The IPL Handpiece produces light pulses with a specific duration, intensity, and spectral distribution allowing for a controlled and confined energy delivery into tissue. IPL use in dermatology relies on the basis that certain targets for energy absorption (chromophores) are capable of absorbing energy from this broad spectrum of light wavelength (absorptive band) without exclusively being targeted by their highest absorption peak. The IPL Handpiece has various filters to create different wavelengths. The handpiece is Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Each wavelength has its own indications for use, which are listed in the tables below. Filters for the non-invasive IPL handpiece include 430nm, 515nm, 560nm, 585, 640nm, and 700nm. The user can select two treatment modes: ST (Skin Type) and HR (Hair Removal) when using the IPL handpiece. The RF Microneedling handpiece operates using sterile, single-use, multi-needle tips (10 pin and 25 pin) and is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The RF Microneedling handpiece generates radiofrequency (RF) energy by means of bipolar RF at 2 MHz. The RF handpiece penetrates micro needles directly into the skin and delivers high frequency energy. This energy flows through the electrode to the tissue and uses heat generated by load or contact resistance to induce coagulation. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The RF Microneedling Handpiece has a single use sterile disposable cartridge. This is the only sterile component on the device. The RF Microneedling handpieces are not intended to be sterilized or disinfected by the end user. The Thermal RF Handpiece is indicated for heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation.
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    K Number
    K210129
    Device Name
    RF Thermal System
    Date Cleared
    2021-07-20

    (182 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Luvo Medical Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Heating for the purpose of elevating tissue temperature for selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation
    Device Description
    The Thermal RF System is a Class II Medical Device that utilizes monopolar RF energy for the purpose of elevating tissue temperature for selected medical conditions. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics and the user interface. It then has a handpiece that is attached to the console, and through the user interface can be selected for administering the treatment.
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    K Number
    K203728
    Device Name
    Darwin
    Date Cleared
    2021-07-14

    (205 days)

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

    Luvo Medical Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Diode Laser Handpiece is indicated for: The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as 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. Use on all skin types (Fitzpatrick I-VI) including tanned skin The IPL Handpieces are indicated for: Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Indication for Use for the 430-980nm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. · For use on Fitzpatrick skin types (I-V) Indication for use for the 515-980mm wavelength • Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, poikiloderma of Civate and Lentigines. • For use on Fitzpatrick skin types (I-V) Indication for use for the 560-980nm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, poikiloderma of Civate and Lentigines. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V) Indication for use for the 585-980mm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types Indication for use for the 640-980mm wavelength . Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. • Benign cutaneous vascular lesions, including port wine stains, hemangiomas, facial and truncal telangiectasias, angiomas, and poikiloderma of Civatte. • The removal of unwanted hair to effect stable long-term or permanent hair reduction • For use on Fitzpatrick skin types (I-V) Indication for use for the 700-980m wavelength · The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the 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 regime • For use on Fitzpatrick skin types (I-V) The RF MicroNeedling Handpiece is indicated for: Use in dermatologic and general surgical procedures for electro-coagulation and hemostasis
    Device Description
    The Darwin is a Class II Medical Device that combines multiple technologies into one platform for use in dermatologic and aesthetic procedures. The system is comprised of a micro-processor-controlled and user-friendly console that houses the power supply, the electronics, and the user interface. It then has 3 handpieces that are attached to the console, and through the user interface can be selected for use in the treatments. There are 3 separate handpieces. Each handpiece has its own indication for use. - Diode Laser Handpiece - IPL Handpiece - RF Microneedling Handpiece ● The Diode Laser handpiece uses laser light in the 808nm wavelength for hair removal. The laser eliminates hair, employing a method knows as selective photothermolysis. This involves disabling hair regrowth mechanism by raising the temperature of the hair follicle high enough to irreversibly damage the follicle's germinative cells without damaging the epidermis and the surrounding tissue. The germinative root resides inside the follicle but is located to the outer follicles sheath. Therefore, the complete follicle volume must be heated above 70° C to accomplish permanent destruction of all stem cell. Delivering a pulsed light using a coherent light source of 808nm wavelength, the diode laser handpiece is intended for hair removal and permanent hair reduction on skin types (Fitzpatrick skin types I - V). The user can choose from two modes: hair removal shot (HRS) and hair removal moving (HRM) when using the Diode laser handpiece. The IPL Handpiece produces light pulses with a specific duration, intensity, and spectral distribution allowing for a controlled and confined energy delivery into tissue. IPL use in dermatology relies on the basis that certain targets for energy absorption (chromophores) are capable of absorbing energy from this broad spectrum of light wavelength (absorptive band) without exclusively being targeted by their highest absorption peak. The IPL Handpiece has various filters to create different wavelengths. The handpiece is Intended for use in aesthetic and cosmetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Each wavelength has its own indications for use, which are listed in the tables below. Filters for the non-invasive IPL handpiece include 430nm, 515nm, 560nm, 585, 640nm, and 700nm. The user can select two treatment modes: ST (Skin Type) and HR (Hair Removal) when using the IPL handpiece. The Needle RF handpiece operates using sterile, single-use, multi-needle tips (10 pin and 25 pin) and is intended for use in dermatologic and general surgical procedures for electro-coagulation and hemostasis. The RF Microneedling handpiece generates radiofrequency (RF) energy by means of bipolar RF at 2 MHz. The RF handpieces penetrates micro needles directly into the skin and delivers high frequency energy. This energy flows through the electrode to the tissue and uses heat generated by load or contact resistance to induce coagulation. The RF energy is delivered through the skin into the target tissue via a handpiece equipped with an electrode tip. As the RF energy passes through the tissue, it generates an electrothermal reaction which is capable of coagulating the tissue. The RF Microneedling Handpiece has a single use sterile disposable cartridge. This is the only sterile component on the device. No handpieces or accessories are intended to be sterilized or disinfect by the end user. There are no components of the Darwin that are reusable.
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    K Number
    K193446
    Device Name
    Bare: 808
    Date Cleared
    2020-03-10

    (89 days)

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

    LUVO Medical Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The hair removal single (HRS) and hair removal moving (HRM) mode are intended for permanent reduction in hair regrowth defined as 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. Use on all skin types (Fitzpatrick I-VI) including tanned skin.
    Device Description
    The Bare : 808 Laser is a microprocessor-controlled, user friendly, sealed diode laser system that produces a wavelength of 808nm with a maximum energy of 120Jcm2. The system incorporates a diode laser within each hand piece, and the energy is delivered from the hand piece directly to the desired target. The Bare: 808 Laser consists of a console, a touch screen user interface, a footswitch and 1 handpiece.
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    K Number
    K193072
    Device Name
    Lucent : IPL
    Date Cleared
    2020-03-05

    (122 days)

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

    LUVO Medical Technologies, Inc

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Lucent : IPL is Intended for use in aesthetic applications requiring selective photothermolysis (photocoagulation or coagulation) and hemostasis of soft tissue in the medical specialties of general and plastic surgery, and dermatology. Indication for Use for the 430-980nm wavelength · Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. · Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. · For use on Fitzpatrick skin types (I-V) Indication for use for the 515-980nm wavelength · Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles). and striae. · Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines. · For use on Fitzpatrick skin types (I-V) Indication for use for the 560-980nm wavelength · Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. · Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, poikiloderma of Civatte and Lentigines. · The removal of unwanted hair to effect stable long-term or permanent hair reduction · For use on Fitzpatrick skin types (I-V) Indication for use for the 585-980nm wavelength · Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. · Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. · The removal of unwanted hair to effect stable long-term or permanent hair reduction · For use on Fitzpatrick skin types (I-V) Indication for use for the 640-980nm wavelength · Benign pigmented epidermal and cutaneous lesions including dyschromia, hyperpigmentation, melasma, Ephelides (freckles), and striae. - · Benign cutaneous vascular lesions, including port wine stains, facial and truncal telangiectasias, angiomas and spider angiomas, and poikiloderma of Civatte. - · The removal of unwanted hair to effect stable long-term or permanent hair reduction - · For use on Fitzpatrick skin types (I-V) Indication for use for the 700-980nm wavelength • The removal of unwanted hair and to effect stable long-term or permanent hair reduction. Permanent reduction in hair regrowth is defined as the 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 regime · For use on Fitzpatrick skin types (I-V)
    Device Description
    The LUVO Medical Technologies, Inc. Lucent : IPL is a multi-wavelength non-invasive system for IPL skin treatments, treatment of vascular and pigmented lesions, and hair removal using multiple filters reflecting a wavelength range of 430nm to 980nm. The Lucent : IPL system consists of a system console, electronics and software, cooling system, and handpiece with six filters
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