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510(k) Data Aggregation

    K Number
    K242151
    Device Name
    Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)
    Manufacturer
    Shenzhen Nuon Medical Equipment Co., Ltd
    Date Cleared
    2025-04-08

    (259 days)

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

    Shenzhen Nuon Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radiant Renewal Skincare Wand (Models: HD-44, HD-44A, HD-44B, HD-69, HD-69A) is an over-the-counter device intended for the treatment of full-face wrinkles. The Radiant Renewal Skincare Wand (Models: HD-44C, HD-69B) is an over-the-counter device intended for the treatment of mild to moderate inflammatory acne.
    Device Description
    The Radiant Renewal Skincare Wand (Models: HD-44, HD-44A, HD-44B, HD-44C, HD-69, HD-69A, HD-69B) is a handheld rechargeable device powered by a Lithium-Ion battery, designed for single-patient use. It offers wrinkle reduction through the emission of red light (wavelength: 630nm±10nm) and infrared light (wavelength: 830nm±10nm), yellow light (wavelength: 590nm±10nm), acne treatment through the emission of blue light (wavelength: 415nm±10nm). Model HD-44 offers red and infrared light for wrinkle reduction. Models HD-44A and HD-69A only provide red light for wrinkle reduction. Models HD-44B and HD-69 use only yellow light for wrinkle reduction. And models HD-44C and HD-69B offers blue light for acne treatment. The ergonomic design of the device ensures ease of use, making them suitable for daily home skincare routines. The package includes the main unit, a charging cable, a user manual, a tray. Each model is equipped with a single button to turn the device on or off. The device will automatically shut down after 5 minutes of operation.
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    K Number
    K242700
    Device Name
    Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B)
    Manufacturer
    Shenzhen Nuon Medical Equipment Co., Ltd
    Date Cleared
    2024-12-19

    (101 days)

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

    Shenzhen Nuon Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Radiant Renewal Skincare Lid (Model: HD-59A. HD-72, HD-73A. HD-116. HD-53A) is intended for the treatment of wrinkles for over-the-counter cosmetic use. The Radiant Renewal Skincare Lid (Model: HD-70) is intended for the treatment of wrinkles and the mild to moderate inflammatory acne for over-the-counter cosmetic use. The Radiant Renewal Skincare Lid (Model: HD-59D, HD-72A, HD-73B,HD-116A,HD-53B) is intended for the treatment of the mild to moderate inflammatory acne for over-the-counter cosmetic use.
    Device Description
    The Radiant Renewal Skincare Lid (Model: HD-59A, HD-59B, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B) is a hand-held, rechargeable device powered by a lithium-Ion battery, designed for single-patient use. It offers wrinkle reduction through the emission of red light (wavelength: 630nm±10nm) and infrared light (wavelength: 830nm±10nm) and yellow light (wavelength: 630nm±10nm), and acne treatment through the emission of blue light(wavelength: 415nm±10nm). There are 12 models of the device, each with similar core functionalities, but differing in the specific light treatments and additional features they offer. Model HD-59A offers red and infrared light for wrinkle treatment, model HD-59B provides yellow light for wrinkle treatment, and model HD-59D uses blue light for acne treatment. These three models differ only in the light treatments they offer. Model HD-70 features three treatment modes: mode 1: Red light and infrared light for wrinkle reduction; mode 2: Yellow light for wrinkle reduction; mode 3: Blue light for acne treatment. Models HD-72, HD-73A, and HD-116 offer two treatment modes: mode 1: Red light for wrinkle reduction; mode 2: Yellow light for wrinkle reduction; Models HD-72A, HD-73B, and HD-116A provide only blue light for acne treatment. The difference between HD-72 and HD-72A, HD-73A and HD-73B, and HD-116 and HD-116A lies in the light treatments they offer. Apart from this, the HD-72 series, HD-73A series, and HD-116 series differ only in appearance. Model HD-53A offers only red light for wrinkle treatment while model HD-53B provides only blue light for acne treatment. The package includes the main unit, a charging cable, a user manual, a tray and a cosmetic container(only for model HD-70). An optional squeeze tube is also available but not included by default. Except for model HD-70, which features an additional rotating rock button, other models are equipped with a single button to turn the device on or off and switch treatment modes. The device can also be used with other skincare products such as face creams, eye creams, serums, etc. The device will automatically shut down after the recommended duration of 2 minutes. If you wish to continue the treatment, simply press the button to turn the device back on.
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    K Number
    K241342
    Device Name
    Hair Growth Comb (SZ-23,SZ-23A)
    Manufacturer
    Shenzhen Nuon Medical Equipment Co., Ltd
    Date Cleared
    2024-11-08

    (179 days)

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

    Shenzhen Nuon Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Hair Growth Comb (Model: SZ-23 ,SZ-23A,) 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 1-1 to 1-4, Il-1, Il-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
    Device Description
    The Hair Growth Comb is (Model: SZ-23, SZ-23A) 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 light reaches 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
    K241155
    Device Name
    Cold Sore Device (QPZ-03)
    Manufacturer
    Shenzhen Nuon Medical Equipment Co., Ltd
    Date Cleared
    2024-09-05

    (133 days)

    Product Code
    OKJ
    Regulation Number
    878.4860
    Why did this record match?
    Applicant Name (Manufacturer) :

    Shenzhen Nuon Medical Equipment Co., Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Cold Sore Device is indicated for shortening the time to healing of herpes simplex labialis lesions on or around the lips with time to healing defined as the time to patient described re-epithelialization.
    Device Description
    The Cold Sore Device is a solid state opto-electronic device that emits a controlled quantity of 1072nm +/- 12nm peak wavelength near infrared light for a period of approximately 3 minutes. The maximum peak light intensity across the treatment surface is 20mW/cm². The light output and duration are monitored by a microprocessor. The tip of the device that contacts the patient is made out of Acrylonitrile Butadiene Styrene (ABS) + PC. Treatment with the device is commenced at the first symptoms of a cold sore 3 times a day with 4 hours in between each treatment for 2 consecutive days. The treatment area is approximately 3 cm². There are 2 light emitting diodes (LEDs) in the treatment area. The light within the device is activated by opening the cover of the device and automatically shut down after the pre-programmed treatment time (3 minutes). The device is designed for external, limited duration skin contact in an environment free from fluids and is provided non-sterile. The LEDs do not come in direct contact with the patient based upon the design of the device. The device is for OTC use and single patient use as described in the patient and box labeling.
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