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510(k) Data Aggregation

    K Number
    K250761
    Device Name
    KALA Therapy Wand (Model: KALA-03)
    Manufacturer
    SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD
    Date Cleared
    2025-07-11

    (120 days)

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

    SHENZHEN KAIYAN MEDICAL EQUIPMENT CO., LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250966
    Device Name
    CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd
    Date Cleared
    2025-06-25

    (86 days)

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

    Shenzhen Kaiyan Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is an over-the-counter device that is intended for the use in the treatment of full-face wrinkles.
    Device Description
    The CurrentBody Skin™ LED Light Therapy Mask Series 2 (Model: MK-90H) is a home use wearable LED phototherapy device whose purpose is to produce an even, cool, narrow band of light for aesthetic indication for treating facial wrinkles. It emits light energy in the red and near infrared (NIR) region of the light spectrum. The device consists of a flexible silicone mask that contains light emitting diodes (LEDs) and a controller, multi-straps, a USB-C charging cord, a pair of eye inserts and a storage bag. The LEDs generate the light. The mask is worn on the face and is held in place by the adjustable strap. The controller contains a rechargeable Lithium ion polymer battery and controls power to the mask. The controller has only one key to switch the LEDs ON/OFF and it will automatically shut down after a 10-minute treatment is completed.
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    K Number
    K251017
    Device Name
    CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd
    Date Cleared
    2025-06-17

    (76 days)

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

    Shenzhen Kaiyan Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CurrentBody Skin Dual Light Hair Growth Helmet is indicated to promote hair growth in males with who have Norwood-Hamilton classifications of IIa-V or females with who have Ludwig-Savin Classifications of I-II and both with Fitzpatrick Skin Phototypes I-IV.
    Device Description
    The CurrentBody Skin Dual Light Hair Growth Helmet (model:MZ-07A) is an over-the-counter device designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V patterns of hair loss and to promote hair growth in females who have Ludwig-Savin Classifications of I-II; both with Fitzpatrick Skin Types I-IV. The device consists of 100 laser diodes with wavelength at 655±5nm, and 200 red light diodes with wavelength at 660±5nm. The CurrentBody Skin Dual Light Hair Growth Helmet includes a hair-growing cap, a device base and a USB power cord. There are LEDs and lasers diodes inside the cap to emit visible red light, the device base acts as a support when the device is not used. There is a power button on cap to turn on/off the device, a digital display to show the remaining treatment time, an power indicator to show charging status and a USB port for charging. The treatment parameter is pre-set by manufacturer, the device will auto off after treatment.
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    K Number
    K250532
    Device Name
    Solawave 2-in-1 Skincare Mini (Model: 61043)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd
    Date Cleared
    2025-05-22

    (87 days)

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

    Shenzhen Kaiyan Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Solawave 2-in-1 Skincare Mini (Model: 61043) is an over-the-counter device that emits energy in the red and infrared spectrum for treating wrinkles on the face and decolletage.
    Device Description
    The Solawave 2-in-1 Skincare Mini (Model: 61043) is a hand-held, battery-powered device that reduce wrinkles by emitting LED red light (630nm) and infrared light (830nm). The device is powered by a Lithium-Ion rechargeable battery, and it comes with a charging cable, storage bag, and instruction manual. The Solawave 2-in-1 Skincare Mini is a revolutionary device that offers two simultaneous approaches for your skin routine in one handheld device: 1. Red and Near-Infrared Light Therapy 2. Warming function (This function is not for medical purpose)
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    K Number
    K241947
    Device Name
    EnergyLounger (TY-01)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd
    Date Cleared
    2025-03-03

    (243 days)

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

    Shenzhen Kaiyan Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    M1 is used to reduce the circumference of the hips, waist and is indicated for use as a noninvasive dermatological. M2 is intended to emit energy in the visible and infrared region of the spectrum for use in the treatment of full-face wrinkles. M3 is intended to emit energy in the visible and IR spectrum intended to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis, pain or muscle spasm, the temporary increase in local blood circulation, and the temporary relaxation of muscles.
    Device Description
    The EnergyLounger, Model: TY-01 a device designed similar to a recliner, with 1260 LED lights, a switch for power on/off, and it can automatically stop treatment after 20 minutes use for M1/M2 and after 30 minutes use for M3, 2 buttons for mode selection, and an AC power supply for power supply. The LED in the EnergyLounger, Model: TY-01 is a 1W imitation current light. It's a 4-in-1 LED, including 630nm, 630nm, 850nm and 940nm.The EnergyLounger, Model: TY-01 includes a detailed Instruction Manual, operators need to read the instructions carefully before use. This device uses three types of LEDs and has three working modes, which can be selected by the user by pressing a button. The device consists of an Energy Lounger, power cable, Product protect cover, Reflector, Goggles and User Manual.
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    K Number
    K242593
    Device Name
    CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd
    Date Cleared
    2025-02-14

    (168 days)

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

    Shenzhen Kaiyan Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For MK-90C: The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90C) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris of the face and use in the treatment of full-face wrinkles. For MK-90M: The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90M) is an over the counter device intended for the use in the treatment of full face wrinkles. For MK66RB-F: The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK66RB-F) is an over the counter device, specifically indicated to treat mild to moderate acne vulgaris. For MK-90N: The CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (Models: MK-90N) is an over the counter device, is generally indicated to treat dermatological conditions and specifically indicated for treatment of periorbital wrinkles.
    Device Description
    The CurentBody™LED 4 in 1 Zone Facial Mapping 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 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 surface, Both surfaces are constructed of silicone The CurentBody™LED 4 in 1 Zone Facial Mapping Mask has 4 models, MK-90C, MK-90M, MK66RB-F and MK-90N.The controller contains a rechargeable lithium battery. The user charges the controller by connecting the charging cable with an adapter (AC100-240V, 50Hz/60Hz 5V 2A).The LED Light Therapy Mask cannot be operated while charging.
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    K Number
    K242363
    Device Name
    HIGHERDOSE Red Light Hat (HG-120K)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd
    Date Cleared
    2024-11-20

    (103 days)

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

    Shenzhen Kaiyan Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HIGHERDOSE Red Light Hat is a home wearable light-emitting diode phototherapy device with proven wavelengths of light 650nm±10nm Red light, which are used to treat Androgenetic Alopecia and promote hair growth in males who have Norwood- Hamilton Classfications of Ila - V patterns of hair loss and to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale 1-1 to 1-4, 11-1, 11-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types 1 - 1V.
    Device Description
    The HIGHERDOSE Red Light Hat is a home wearable light-emitting diode phototherapy device with proven wavelengths of light 650nm±10nm Red light, which are used to treat Androgenetic Alopecia and promote hair growth in males who have Nowood- 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. The device is designed as wearable product, and it consists of the main unit, the controller and a power cable, as well as it is powered by the built-in rechargeable lithium battery. The hat compromises of 2 surfaces. An inner surface that contacts the skin and an outer surface. Both surfaces are constructed of cotton. 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 HIGHERDOSE Red Light Hat cannot be operated while charging. The controller switches the LEDs ON/OFF. Switch the controller ON and allow the hat to run for 10 minutes treatment program. The cable for connecting with the controller is detachable. 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.
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    K Number
    K241933
    Device Name
    HIGHERDOSE Red and Infrared Light Mask (MK66-L)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd
    Date Cleared
    2024-09-27

    (87 days)

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

    Shenzhen Kaiyan Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The HIGHERDOSE Red And Infrared Light Mask (Model: MK66-L) is an over the counter device that is intended for the use in the treatment of full-face wrinkles.
    Device Description
    The HigherDose Red and Infrared Light Mask is a home wearable light-emitting diode phototherapy device with two proven wavelengths of light 630nm and 830nm(near infrared light ) for treatment of fullface wrinkles, The face mask combine Red (630nm)and near infrared light (830nm).Harnessed at the perfect measurement to rejuvenate the skin, these two wavelengths work below the skin's surface to stimulate the natural rejuvenation process ,creating a complexion that is visibly growing and noticeably healthier looking. The mask is worn on the face and is held in place by head 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 HIGHERDOSE Red And Infrared Light 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.
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    K Number
    K240089
    Device Name
    Face Patches (MT-12MA, MT-12MC)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd
    Date Cleared
    2024-04-10

    (89 days)

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

    Shenzhen Kaiyan Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Face Patches (Model: MT-12MA) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne. Face Patches (Model: MT-12MC) is an Over-the-Counter (OTC) device intended for treatment of mild to moderate inflammatory acne and full-face wrinkles (including periorbital wrinkles).
    Device Description
    The Face Patches, Model: MT-12MA and MT-12MC is an over-the-counter light emitting diode (LED) device. Model: MT-12MA can emits 415nm and 630nm energy to treat mild to moderate acne. There is a total of 6 LEDs, providing a power intensity of approximately 30 mW/cm². Model: MT-12MC has 3 modes (mode 1: 630+415nm, mode 2: 630+830nm, mode 3: 590nm), it can emit 630nm and 415 nm energy to treat mild to moderate acne and provide approximately 30 mW/cm²; 630nm and 830nm energy to treat full-face wrinkles and provide approximately 35 mW/cm²; and 590nm energy to treat wrinkles and provide approximately 35 mW/cm². There is a total of 18 LEDs. The device components include the device containing two face patches, a controller, a charging cable, 120 Mini Dots, goggles and user manual. The user pastes the device on the treatment area, and the device will shut down automatically after a 3-minute after finishing treatment. Users should adjust the treatment time based on different modes and actual treatment situations. The device has one button, and delivery of therapy requires the operator to depress a physical switch on the device.
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    K Number
    K233556
    Device Name
    LED Eye mask (EY-20R, A20, EY-20N)
    Manufacturer
    Shenzhen Kaiyan Medical Equipment Co., Ltd
    Date Cleared
    2024-01-04

    (59 days)

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

    Shenzhen Kaiyan Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LED Eye mask (Model: EY-20R, A20, EY-20N) is an Over-the-Counter (OTC) device intended for use in treating wrinkles within the periorbital region.
    Device Description
    The LED Eye Mask, model: EY-20R, A20, EY-20N 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 is 605nm, 633nm, 660nm, 830nm. The LED Eye Mask components contain the main unit. USB cable cord and velcro straps and removable eve protection. There is a total of 40 LEDs to provide a power intensity of about 65 mW/cm². The device has only one button to turn on/off. 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 three models other than the appearance.
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