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510(k) Data Aggregation

    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?
    Product Code :

    OAP

    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
    K250467
    Device Name
    Red Light Hair Growth Cap (LP-RJVGRW-BLK)
    Manufacturer
    Shenzhen Idea Light Limited
    Date Cleared
    2025-06-05

    (107 days)

    Product Code
    OAP, DAT
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    OAP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Red Light Hair Growth Cap is indicated to treat Androgenetic Alopecia and 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 Red Light Hair Growth Cap is an over the counter (OTC) home-use, non-invasive device indicated to treat androgenetic alopecia and 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. The Red Light Hair Growth Cap is a portable, therapeutic device whose purpose is to provide even, cool, narrow-band wavelengths of polychromatic light (660nm red light) produced by LEDs to treat androgenetic alopecia and promote hair grown. The device comprises of a wearable soft textile cap, a controller, an AC adaptor and a USB cable. The device can be powered by the AC adaptor which connected to the mains directly, also it can be powered by a power bank. The device is operated by the controller. There are 2 buttons on controller, ON/Off button is used to turn on/off the device, time button is used for setting treatment time from 10 to 30 minutes, each press in 5-minute increments./decrements. The device will shut off automatically after reach treatment time.
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    K Number
    K250308
    Device Name
    Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)
    Manufacturer
    Dongguan Boyuan Intelligent Technology Co., Ltd.
    Date Cleared
    2025-04-29

    (85 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    OAP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hair Growth Device is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, in males with androgenetic alopecia who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
    Device Description
    The product is composed of main unit, USB cable, and silicone pad. The main unit consists of laser diodes that are spread throughout the helmet. Low-energy laser therapy (LLLT) is a safe and effective treatment for androgenic alopecia (AGA). The Hair Growth Device employs intelligent LLLT technology, utilizing a 650 nm, 5-milliwatt low-energy laser that penetrates the scalp surface to a depth of 3-5 mm, reaching the hair follicles. Hair Growth Device is a small over-the-counter, portable, noninvasive, low-level laser device intended to treat Androgenetic Alopecia (Hair Loss) and to promote hair growth in Males and Females. The product uses diode lasers to cover the entire area of the head that is normally covered with hair, and this unique design allows the treatment of the entire scalp without manual movement. Hair Growth Device consists of main unit, USB cable and silicone strap and no communication function. The device will then turn on and you'll hear an audible beep.
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    K Number
    K242747
    Device Name
    FAQ™ (302)
    Manufacturer
    Foreo Inc.
    Date Cleared
    2024-12-11

    (90 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    OAP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    FAQ™ 302 is indicated to promote hair growth in males with androgenetic alopecia who have Hamilton-Norwood Classifications of Ila-V and females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II and Fitzpatrick Classification of Skin Phototypes I to IV.
    Device Description
    FAQ™ 302 is a handheld rechargeable square shaped device designed for improving hair growth with 20 laser diodes (wavelength 650±10m) and 20 RED LED beads (640-660nm) on the inside surface. By pressing the universal button, the user can power the device on, start treatment and change the intensity by quick-pressing the button again. Once the treatment is complete, the device is turned off by pressing and holding the universal power button for 3 seconds. The device can also be connected wirelessly via Bluetooth to an FAQ App in order to manage treatment. After the treatment is completed, the device automatically powers off. The device uses a non-detachable polymer lithium battery for power supply in compliance with IEC 62133-2:2017+A1:2021 standard.
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    K Number
    K242619
    Device Name
    GroWell BT Hair Growth System (GW10042)
    Manufacturer
    Apira Science Inc
    Date Cleared
    2024-12-02

    (90 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    OAP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MEN - The GroWell BT Hair Growth System ("GroWell") is designed to promote hair growth in males with androgenetic alopecia who have Norwood Hamilton Classifications of Ila to V. WOMEN - The GroWell is designed to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin classifications of I-II. The GroWell is approved for Fitzpatrick skin types I-IV.
    Device Description
    The GroWell BT Hair Growth System consists of 24 proprietary red light diode lasers and 39 proprietary red light super-luminescent diodes configured in a flexible panel which is inserted in an adult, baseball-style cap. The GroWell contains 655nm laser and LED diodes, which generates light after being excited by the internal power supply, the light is controlled and output by the control device, and directly and effectively irradiated to the treatment site, so as to achieve therapeutic effect. The GroWell's conbination of diode lasers and non-laser LED's provides for a full coverage of the head: i.e, the scalp area roughly from the top of the head to the top of the ears. The GroWell session will be "paused" and the light array will automatically turn off if the user removes the GroWell during use, and will resume when it is replaced on the 25 minute session, the lights will turn off and the GroWell will emit two audible beeps to signal that the therapy is complete.
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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?
    Product Code :

    OAP

    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
    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?
    Product Code :

    OAP

    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
    K242620
    Device Name
    Breo Laser Hair Growth Comb (Scalp 3L)
    Manufacturer
    Shenzhen Breo Technology Co., Ltd.
    Date Cleared
    2024-11-01

    (59 days)

    Product Code
    OAP, ISA
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    OAP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Breo Laser Hair Growth Comb is indicated to treat Androgenetic Aloperia, and promote hair growth in females who have Ludwig (Savin) 1-4, II-1, II-2, or frontal patterns of hair loss and in males who have Norwood Hamilton Classifications of IIa to V and who both have Fitzpatrick Skin Types I to IV.
    Device Description
    Breo Laser Hair Growth Comb is a hand-held comb-shaped low level laser therapy device that emits laser light designed to promote hair growth in women and men. The device provides distributed laser light to the scalp while the comb teeth simultaneously part the user's hair to ensure the laser light reaches the user's scalp. The device also has a massage function which is a mechanical vibration function.
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    K Number
    K240472
    Device Name
    PBM Hair Therapy Cap
    Manufacturer
    Dongguan Tutamen Metalwork Co., Ltd
    Date Cleared
    2024-10-11

    (234 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    OAP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PBM Hair Therapy Cap is indicated to treat Androgenetic Alopecia and promote hair growth in females who have Ludwig-Savin Scale I to II, males who have Norwood Hamilton Classifications of Ila to V patterns of hair loss, females and males with frontal patterns of hair-loss both with Fitzpatrick Skin Types I to IV.
    Device Description
    The PBM Hair Therapy Cap is a hair therapy device that uses red light to help stimulate hair growth in both male and females. The device comes with a Cap that has LED diodes inbuilt and an attachable controller battery pack that comes with an automatic timer that limits the user to 15-minute sessions. The device uses only 660nm LED wavelength diodes on 7 strips, each strip has 12 diodes. These diodes strips are sewn into a cap and has a Type C USB connector that the controller battery pack can connect to. The PBM Hair Therapy Cap is comprised of a fabric cap with inbuilt LED diodes that emit red light on the wavelength of 660nm. The diodes are on strips and the cap style hat has 7 strips with 12 diodes on each strip with a total of 84 LED diodes. A battery powered controller that attaches via a C-type USB connector to the fabric hat is also provided. The controller has a built in 3.7V lithium-ion battery, has an on/off button and in programmed to automatically turn of after 15min of use. The controller also has a 2 small indicator LED's for indicating, power on/in use, needs charging and also blinks while in charging mode. The controller charges via inbuilt C-Type USB port and charges at 500 mA.
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    K Number
    K240689
    Device Name
    Robin's Egg
    Manufacturer
    Telebrands Corporation
    Date Cleared
    2024-09-17

    (188 days)

    Product Code
    OAP
    Regulation Number
    890.5500
    Why did this record match?
    Product Code :

    OAP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Robin's Egg is indicated to treat Androgenetic Alopecia and 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-I to I-4, II-I, II-2 or frontal patterns of hair loss; both with Fitzpatrick Skin Types I - IV.
    Device Description
    The Telebrands' Robin's Egg is a non-invasive, helmet-style photobiomodulation device indicated to treat androgenetic alopecia in both men and women. It is operated using a single button at the front of the helmet to promote hair growth using Modulated Light Therapy (MLT) for a recommended 10-minute daily treatment. The Robin's Egg is a system comprised of a wearable soft textile Cap using driver electronics, a rechargeable battery, and integrated light emitting diode (LED) flexible printed circuit board containing 126 LEDs, as compared to 119 within the predicate device REVIAN RED. The Robin's Egg is designed as an over-the-counter (OTC) home-based device to treat the entire scalp area of the user and is controlled by means of a single button and illuminated control display at the front of the helmet. Emitting red light energy within the 625 - 660 nm at 2.376 mW/cm² for a treatment time of 10 minutes, the Robin's Egg provides a well-established photobiomodulation effect upon the scalp to stimulate hair growth.
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