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510(k) Data Aggregation

    K Number
    K230720
    Device Name
    LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
    Manufacturer
    Light Tree Ventures Europe B.V.
    Date Cleared
    2023-07-03

    (109 days)

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

    Light Tree Ventures Europe B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LUSTRE 3XPRESS Light Beauty Therapy patches (Model: PR6001, PR5001) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne.
    Device Description
    The LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001 and PR5001 is an over-the-counter light emitting diode (LED) device that emits energy to treat mild to moderate acne. The device uses two types of LEDs: 415 nm and 630nm. The LUSTRE 3XPRESS Light Beauty Therapy patches components include the device containing two Light Beauty Therapy Patches, an USB Cable with an integrated controller, 120 Mini Dots, a Goggles, a Travel pouch and a User Manual. Among them, mini dots are used for fixed device, goggles are used to protect eyes, and travel pouch are used to store device. There is a total of 24 LEDs for each model to provide a power intensity of about 30 mw/cm². The user pastes the device on the treatment area, and the device will shut down automatically after a 3minute after finishing treatment. The two models are only different in shape. PR6001 is triangular and PR5001 is crescent.
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    K Number
    K223893
    Device Name
    Infrared Heat (Model: E0221)
    Manufacturer
    Light Tree Ventures Europe B.V.
    Date Cleared
    2023-05-16

    (139 days)

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

    Light Tree Ventures Europe B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Infrared Heat (Model: E0221) is intended to emit energy in the red and infrared spectrum for use in the treatment of full face wrinkles.
    Device Description
    The Infrared Heat, model: E0221, is an over-the-counter light emitting diode (LED) device that emits 630nm and 830nm light to treat wrinkles. The device uses three types of LEDs and has two modes to reach those two functions. The user can control the treatment time or automatically shut it off within a set time. The Infrared Heat components include the main unit device (a pad), an adjustable strap, a USB charging cord, goggles and a user manual. The user wears the device in the area which needs to treat, and the device will shut down automatically a 10-minute after finishing treatment.
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    K Number
    K230042
    Device Name
    Q-Rejuvalight Pro Facewear (Model: P19-0023)
    Manufacturer
    Light Tree Ventures Europe B.V.
    Date Cleared
    2023-04-28

    (112 days)

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

    Light Tree Ventures Europe B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The O-Rejuvalight Pro Facewear (Model: P19-0023) is an Over-the-Counter (OTC) device intended for treatment of wrinkles and mild to moderate inflammatory acne.
    Device Description
    The Q-Rejuvalight Pro Facewear is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of wrinkles and mild to moderate inflammatory acne. The device uses four types of LEDs for Wrinkles: 605nm, 660nm, and 880nm and two types of LEDs for Acne: 415nm and 630nm. Each mode takes 3 minutes (±3s) for a course of treatment, and the mask will automatically turn off at the end of time. The Q-Rejuvalight Pro Facewear components include the main device, head strap, eye rest, Latch, User Manual, Storage bag and USB power cord. The Q-Rejuvalight Pro Facewear is applied directly to the skin to ensure consistent administration of light during each treatment. The device does not contain any user serviceable components.
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    K Number
    K230597
    Device Name
    Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
    Manufacturer
    Light Tree Ventures Europe B.V.
    Date Cleared
    2023-04-28

    (56 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Light Tree Ventures Europe B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Aduro Comb (Model: SZ-22A) is indicated to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classifications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I-1 to I-4, II-1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
    Device Description
    The Aduro Comb is (Model: SZ-22A) a comb-shaped device that emits led light with the intention to promote hair growth. The device provides distributed led to the scalp at 650nm (±10nm) while the comb teeth simultaneously part the user's hair to ensure the user's scalp. The device is designed as a handheld product, and it consists of the main unit, the charging dock and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The device has only one key for switching on and off the device and it will automatically shut down after a 10-minute treatment is completed.
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    K Number
    K230336
    Device Name
    CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
    Manufacturer
    Light Tree Ventures Europe B.V.
    Date Cleared
    2023-04-05

    (57 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Light Tree Ventures Europe B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CurrentBody Skin™ Led Hair Regrowth (MZ-07) is indicated to treat Androgenetic Alopecia and to Promote Hair Growth in males who have Norwood-Hamilton Classifications of IIa - V patterns of hair loss and to treat Androgenetic Alopecia and Promote Hair Growth in females who have Ludwig-Savin Scale I-1 to I-4, II -1, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
    Device Description
    The CurrentBody Skin™ Led Hair Regrowth, model: MZ-07 is an over-the-counter light-emitting diode (LED) device designed to promote hair growth in women and men by exposing the entire scalp to the photostimulation of visible red light-emitting diodes at 660nm. The CurrentBody Skin™ Led Hair Regrowth includes a hair-growing cap, a device base and a USB power cord. The user turns on the device and then wears the device on his/her head, and the device will turn off automatically after a 10-minute treatment default.
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    K Number
    K230124
    Device Name
    LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
    Manufacturer
    Light Tree Ventures Europe B.V.
    Date Cleared
    2023-03-15

    (57 days)

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

    Light Tree Ventures Europe B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LUSTRE ClearSkin Renew Pro Facewear Mask is an over-the-counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the use in the treatment of full-face wrinkles.
    Device Description
    LUSTRE ClearSkin Renew Pro Facewear Mask (Model: PR4001) is an over-the-counter light emitting diode (LED) device that emits energy for use in dermatology for the treatment of acne and wrinkles. The device has anti-wrinkle mode and anti-acne, the former is to emit red light (630nm) and infrared light (830nm) to treat wrinkles, the latter is to emit red light (630nm) and blue light (415nm) to treat mild to moderate acne. There is only one button on the outside of the mask, which have the functions of controlling startup, shutdown, and switching modes. The treatment lasts for 10 minutes by default, and after the treatment, the device will automatically shut down if it is not operated within five minutes. The product contents include an LED mask, Adjustable Velcro Straps, Removable Eye Protection, USB-C cable, cloth bag and user manual, the function of the Removable Eye Protection is to protect the eyes from the harm of led light.
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    K Number
    K223642
    Device Name
    LED Lip Perfector, model: ZC-05
    Manufacturer
    Light Tree Ventures Europe B.V.
    Date Cleared
    2023-03-09

    (93 days)

    Product Code
    ILY, OHS
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    Light Tree Ventures Europe B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LED Lip Perfector (Model: ZC-05) is an Over-the-Counter (OTC) device intended to treat fines and wrinkles and increase in circulation within the perioral region.
    Device Description
    The LED Lip Perfector (Model: ZC-05) is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat fine lines and increase circulation within the perioral region. The device contains four types of LEDs: 605nm, 630nm, and 850nm The LED Lip Perfector components include the main device, charging base, power cord, alternative mouthpiece, user manual, and storage bag. There is only one button on the top edge of the main unit. Short press the power button to turn on the device, and long press the power button to turn off the device. This device only has one treatment mode. The LED Lip Perfector is applied to the skin to ensure consistent light administration during each treatment. The device is sold Over the Counter (OTC).
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    K Number
    K221775
    Device Name
    LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
    Manufacturer
    Light Tree Ventures Europe B.V.
    Date Cleared
    2022-12-20

    (182 days)

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

    Light Tree Ventures Europe B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For MK-78, MK-04, The LED Light Therapy Mask (Models: MK-78, MK-04) is an over the counter device that is intended for the use in the treatment of full-face wrinkles. For MK66-H, EL00003 The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and blue region of the light spectrum, specifically indicated to treat mild to moderate acne vulgaris of the face. The LED Light Therapy Mask (Models: MK66-H, EL00003) is an over the counter device intended to emit energy in the red and Near Infra-red spectrum and is intended for the treatment of full-face wrinkles.
    Device Description
    The LED Light Therapy Mask is a home wearable light-emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles, or mild to moderate acne vulgaris of the face. The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by adjustable Velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surfaces are constructed of silicone. The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The LED Light Therapy Mask cannot be operated while charging. The device is not used to make measurements of any sort, or to draw any conclusions regarding the indication to treat. The device does not require checks on the light output as the LEDs do not dim with age to any practical extent. Models MK-78, and MK-04 produce red and near infra-red (NIR) light in the visible spectrum (Red: 630+/-5nm, NIR: 830nm) in intended to improve the appearance of wrinkles. The controller switches the LEDs ON/OFF and controls power to the mask. For MK-04, the cable for connecting with the controller is nondetachable, but the cable is detachable for MK-78. Model MK-04 contains many rose quartz crystals in inner surface for decoration purpose, the crystals do not contact with skin and there is no therapeutic effect. Model MK66-H and EL00003 produce blue, red, and near infra-red (NIR) light in the visible spectrum (Blue: 415nm, Red: 630+/- 5nm, NIR: 830nm). The device works by emitting the specified wavelengths into the skin in order to improve the appearance of wrinkles or to target bacteria that can cause acne vulgaris. The controller switches the LEDs ON/OFF, controls power to the mask, and switches treatment modes. The cable for connecting with the controller is detachable. Both MK66-H and EL00003 have two pieces of removable eye protection which are for protect eyes from the light.
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    K Number
    K221444
    Device Name
    LED Eye Perfector, model: EY-36A, EY-36B
    Manufacturer
    Light Tree Ventures Europe B.V.
    Date Cleared
    2022-12-08

    (204 days)

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

    Light Tree Ventures Europe B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LED Eye Perfector (Model: EY-36A, EY-36B) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.
    Device Description
    The LED Eye Perfector, model: EY-36A and EY-36B is an over-the-counter light-emitting diode (LED) device that emits energy for dermatology to treat wrinkles within the periorbital region. The device uses four types of LEDs, and for model EY-36A: 605 nm, 633 nm, 660nm, 830 nm, for EY-36B: 605 nm, 625 nm, 660nm, and 880 nm. The treatment time can be controlled by the user, or automatically shut off within a set time. The LED Eye Perfector components contain the main unit device, charging base, USB charging cord, velcro straps and goggles. There is a total of 40 LEDs to provide a power intensity of about 65 mW/cm². The user wears the device on their eye area for the treatment, and the device will shut down automatically after a 3-minute after finishing treatment. There are no differences between the two models other than the output wavelength.
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    K Number
    K221946
    Device Name
    LED Light Therapy Mask (model: MK66R-B)
    Manufacturer
    Light Tree Ventures Europe B.V.
    Date Cleared
    2022-11-22

    (140 days)

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

    Light Tree Ventures Europe B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LED Light Therapy Mask (Model:MK66R-B) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.
    Device Description
    The LED LIGHT THERAPY MASK is a home wearable light-emitting diode phototherapy device whose purpose is to produce an even, cool, narrow band of light for the treatment of full-face wrinkles. The system consists of a flexible silicone mask that contains LEDs and a controller. The mask is worn on the face and is held in place by velcro straps. The mask compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of sillcone. The controller contains a rechargeable Lithium battery, the power supply (adaptor) is used to charge the Lithium battery and is connected to a suitable mains outlet via a 2 or 3 pin input socket and wall plug. The LED LIGHT THERAPY MASK cannot be operated while charging. The controller switches the LEDs ON/OFF and controls power to the mask. The device does not have an adapter, please use adapters of the following specifications: input: 100-240Va.c., 50Hz/60Hz, output: DC 5V, 2A. The device produces red and near infra-red (NIR) light in the visible spectrum (Red: 630+/-5nm, NIR: 830nm) in intended to improve the appearance of wrinkles. The controller switches the LEDs ON/OFF and controls power to the mask. And the cable for connecting with the controller is non-detachable.
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