Search Filters

Search Results

Found 10 results

510(k) Data Aggregation

    K Number
    K250384
    Device Name
    IPL400
    Manufacturer
    EL Global Trade Ltd
    Date Cleared
    2025-05-23

    (101 days)

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

    EL Global Trade Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Ice Cooling IPL Hair Removal Device with sapphire treatment window is indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9 and 12 months after the completion of a treatment regime.
    Device Description
    Ice Cooling IPL Hair Removal Device is an over-the-counter, home-use and personal device for hair reduction by using Intense Pulsed Light (IPL). It is designed with a lamp that can emit single pulse, double pulse or triple pulse per shot. It works below the skin's surface and does not involve any cutting or pulling, reducing hair growth with nearly painless pain. The device is only powered by the external power adapter and its IPL emission activation is by finger switch. This product adopts sapphire treatment window that is suitable for multiple hair removal areas. It contains a skin sensor to detect appropriate skin contact, if the device is not in full contact with the skin, the device cannot emit the treatment light pulses. Besides, the device has the ice cooling function that will be activated throughout the whole hair removal process to provide users with a more comfortable experience.
    Ask a Question
    K Number
    K232424
    Device Name
    CurrentBody Skin RF
    Manufacturer
    EL Global Trade Ltd.
    Date Cleared
    2024-03-06

    (208 days)

    Product Code
    PAY
    Regulation Number
    878.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    EL Global Trade Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The CurrentBody Skin RF (ST030) device is an over-the-counter home-use device intended for non-invasive treatment of mild to moderate facial wrinkles for adults with Fitzpatrick skin types I-IV.
    Device Description
    The CurrentBody Skin RF device is an OTC, home-use hand-held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of: User Interface, Programmable logic controller (PLC, microcontroller) embedded in PCBA, RF power module, Power Supply, RF electrodes. The PLC (on the PCBA) is a specially configured software that, combined with hardware circuits, provides the operational and safety function of the system. The RF power module provides RF energy to the active tip electrodes, producing a signal of 1MHz frequency (power limited by hardware). This device is supplied non-sterile.
    Ask a Question
    K Number
    K183260
    Device Name
    Sensilight Pro / Pistol IPL
    Manufacturer
    EL Global Trade Ltd.
    Date Cleared
    2019-03-18

    (115 days)

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

    EL Global Trade Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Sensilight Pro device is an over-the-counter device intended for the removal of unwanted body and/or facial hair. Sensilight Pro is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured 6,9 and 12 months after the completion of treatment regimen.
    Device Description
    The Sensilight Pro is an intense pulse light hair reduction device. Phototherapy (Lightbased) hair reduction is based on the theory of selective photothermolysis in which optical energy is used to disable hair re-growth. The Sensilight Pro is composed of a hand-held applicator and an external power supply/charger. The spot size (treatment area) in the Sensilight Pro is 4.5 cm² or 2 cm² (for large and precise treatment windows, respectively). The device contains a lamp, a skin proximity and pigmentation sensor allowing application only on compatible skin tones and while in full contact with the treated area. If the Sensilight Pro is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the device will provide indications on the faulty conditions and will not trigger a pulse.
    Ask a Question
    K Number
    K181095
    Device Name
    RF-Relief
    Manufacturer
    EL Global Trade Ltd
    Date Cleared
    2018-07-24

    (89 days)

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

    EL Global Trade Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The RF-Relief is an over the counter hand held device intended to emit energy in RF spectrum to provide topical heating for the purpose of elevating tissue temporary relief of minor muscular and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local blood circulation, and temporary relaxation of muscles.
    Device Description
    The RF-Relief is an OTC, home use device, designed to deliver RF energy and mechanical skin massaging. RF energy does not cause thermal damage to the treated skin and the subdermal adipose layer. The level of the RF power, to achieve maximum comfort is user selectable. The ergonomic hand held device allows efficient treatment of the indicated body areas. It is a non-invasive, non-ablative device and it is supplied as non-sterile. The RF-Relief device consists of power supply, RF power generator, Programmable Logic Controller (PLC, microcontroller) embedded in PCBA and user interface. The device also includes four Bi-polar (2 pairs) electrodes, two redundant temperature sensors and a vibration motor. The PLC (on the PCBA) is especially configured software combined with hardware circuits that provides the operational and safety function of the system. The RF-Relief device is operated while continuously moving it over the treatment area. This ensures a uniform distribution of the RF energy together with mechanical massage over the entire treatment area.
    Ask a Question
    K Number
    K172181
    Device Name
    micro IPL
    Manufacturer
    EL Global Trade Ltd
    Date Cleared
    2017-10-13

    (86 days)

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

    EL Global Trade Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The micro IPL is an over the counter device intended for the removal of unwanted body and/ or facial hair in adults. The micro IPL is also intended for permanent reduction in unwanted hair reduction is defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
    Device Description
    The micro IPL device is pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The micro IPL device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the micro IPL device is 3 cm . The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the micro IPL is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned. the micro IPL will not trigger a pulse.
    Ask a Question
    K Number
    K170637
    Device Name
    sensiFirm
    Manufacturer
    EL Global Trade Ltd
    Date Cleared
    2017-07-14

    (134 days)

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

    EL Global Trade Ltd

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sensiFirm device is intended for the following medical conditions using non thermal RF combined with massage: Temporary reduction in the appearance of cellulite.
    Device Description
    The sensiFirm is an OTC, home use device, designed to deliver non-thermal RF energy and mechanical skin massaging. RF energy does not cause thermal damage to the treated skin and the subdermal adipose layer. The level of the non-thermal RF power, to achieve maximum comfort is user selectable. The ergonomic hand held device allows efficient treatment of the indicated body areas. It is a noninvasive, non-ablative device and it is supplied as non-sterile. The sensiFirm device consists of power supply, RF power generator, Programmable Logic Controller (PLC, microcontroller) embedded in PCBA and user interface. The device also includes a vibration motor, four Bi-polar (2 pairs) electrodes and two redundant temperature sensors. The PLC (on the PCBA) is specially configured software combined with hardware circuits that provides the operational and safety function of the system. The sensiFirm device is operated while continuously moving it over the treatment area. This ensures a uniform distribution of the non-thermal RF energy together with mechanical massage over the entire treatment area.
    Ask a Question
    K Number
    K170499
    Device Name
    sensiLift
    Manufacturer
    EL GLOBAL TRADE LTD
    Date Cleared
    2017-06-15

    (118 days)

    Product Code
    PAY
    Regulation Number
    878.4420
    Why did this record match?
    Applicant Name (Manufacturer) :

    EL GLOBAL TRADE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sensiLift is an over-the-counter home use device intended for non-invasive treatment of mild to moderate facial wrinkles for adult women who have Fitzpatrick Skin Types I-IV.
    Device Description
    The sensiLift is an OTC, home use hand held device generating pulses of radiofrequency (RF) energy that are emitted into the skin. RF energy heats the tissue to improve the appearance of wrinkles and rhytides. It is a non-invasive, non-ablative device consisting of: - . User Interface - Programmable logic controller (PLC, microcontroller) embedded in PCBA ● - RF power module - Power Supply ● - RF electrodes ●
    Ask a Question
    K Number
    K161089
    Device Name
    sensiLight Mini
    Manufacturer
    EL GLOBAL TRADE LTD
    Date Cleared
    2016-07-08

    (81 days)

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

    EL GLOBAL TRADE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sensiLight Mini is an over the counter device intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
    Device Description
    The sensiLight Mini device is a pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The sensiLight Mini device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight Mini device is 3 cm2. The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight Mini will not trigger a pulse.
    Ask a Question
    K Number
    K140381
    Device Name
    SENSILIGHT/ SENSILIGHT PLUS
    Manufacturer
    EL GLOBAL TRADE LTD.
    Date Cleared
    2014-08-08

    (175 days)

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

    EL GLOBAL TRADE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sensiLight™ Plus device is an over-the-counter device intended for the removal of unwanted hair. The sensiLight™/sensiLight™ Plus is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of treatment regimen.
    Device Description
    The sensiLight devices are pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The sensiLight devices are composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight devices is 3 cm². The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight will not trigger a pulse. (*) The sensiLight Plus model contains in addition, a movement sensor to prevent pulse overlapping.
    Ask a Question
    K Number
    K140527
    Device Name
    SENSILIGHT MINI
    Manufacturer
    EL GLOBAL TRADE LTD.
    Date Cleared
    2014-07-31

    (149 days)

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

    EL GLOBAL TRADE LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The sensiLight Mini is an over the counter devices intended for the removal of unwanted hair. The sensiLight Mini is also intended for permanent reduction in hair regrowth, defined as a long-term, stable reduction in the number of hairs re-growing when measured at 6, 9, and 12 months after the completion of treatment regimen.
    Device Description
    The sensiLight Mini device is pulsed light hair removal device. Light-based hair removal is based on the theory of selective photothermolysis in which optical energy is used to disable hair growth. The sensiLight Mini device is composed of a hand held applicator and an external power supply. The spot size (treatment area) in the sensiLight Mini device is 3 cm2. The device contains a lamp, a skin proximity sensor and a skin pigmentation sensor to detect appropriate skin tones. If the sensiLight Mini is not properly applied (in full contact with the skin) or user skin tone is too dark/tanned, the sensiLight Mini will not trigger a pulse.
    Ask a Question

    Page 1 of 1