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510(k) Data Aggregation

    K Number
    K222081
    Device Name
    ID-510 iRestore Elite
    Manufacturer
    Freedom Laser Therapy, Inc.
    Date Cleared
    2022-10-13

    (90 days)

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

    Freedom Laser Therapy, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ID-510 iRestore Elite is indicated to promote hair growth in males who have Norwood-Hamilton Classifications of IIa-V, and in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, and in both, Fitzpatrick Classification of Skin Phototypes I to IV.
    Device Description
    The ID-510 iRestore Elite is a low-level laser/light system operating at 680 ± 10, 655 ± 10, and 625± 10 nanometers. The physical configuration is that of a helmet containing an inner and outer liner, stabilized with a silicone pad lined fixation ring. The device helmet is constructed of an ABS type plastic. The system operates on line voltage at 100 or 240 volts. The helmet's inner liner permits full adjustment to any heads of non-toxic silicone pads. The helmet contains 300 units of five-millwatt-diode lasers and 200 units of fivemilliwatt, super luminescent diodes, that emit red light. This system delivers fixed laser emission levels, measured to be 2500 total millwatts per 12 minute treatment session, which cannot be altered by the operator.
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    K Number
    K213094
    Device Name
    ID-500 iRestore Hair Growth System
    Manufacturer
    Freedom Laser Therapy, Inc.
    Date Cleared
    2021-12-22

    (89 days)

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

    Freedom Laser Therapy, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ID-500 iRestore Hair Growth System: iRestore Hair Growth System, ID-500, is indicated to treat androgenetic alopecia for men and women. It is designed to promote hair growth in males who have Norwood-Hamilton Classifications of IIa to V and in females who have Ludgwig-Savin Classifications of I to II. All users should also have Fitzpatrick Skin Types I to IV.
    Device Description
    The ID-500 iRestore Hair Growth System are two low-level laser/light systems operating at different wavelengths. The ID-500 iRestore Hair Growth System consists of laser and LED operating at 655 ± 10 nanometers. The physical configuration of the device is that of a helmet containing an inner and outer liner, stabilized with a silicone pad lined fixation ring. The systems operate on line voltage at 100 or 240 volts. The helmet's inner liner permits full adjustment to any head shape by means of non-toxic silicone pad. The helmet contains 5-millwatt-diode lasers and 5-milliwatt, super luminescent diodes, that emit red light.
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    K Number
    K183417
    Device Name
    iRestore Professional 282
    Manufacturer
    Freedom Laser Therapy, Inc.
    Date Cleared
    2019-05-17

    (158 days)

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

    Freedom Laser Therapy, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iRestore Professional 282 is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I-II, males who have Norwood-Hamilton Classifications of IIa-V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
    Device Description
    The iRestore Professional 282 consists of 82 red visible light, diode lasers and 200 red light super-luminescent diodes configured within an outer helmet and protective inner. The use of diode lasers and non-laser LEDs provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down. by emitting an audible beep pattern.
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    K Number
    K151662
    Device Name
    iRestore
    Manufacturer
    Freedom Laser Therapy, Inc.
    Date Cleared
    2016-01-06

    (201 days)

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

    Freedom Laser Therapy, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The iRestore Hair Growth System is indicated to promote hair growth in females with androgenetic alopecia who have Ludwig-Savin Classifications of I- II, males who have Norwood-Hamilton Classifications of IIa- V and for both, Fitzpatrick Classification of Skin Phototypes I to IV.
    Device Description
    The iRestore Hair Growth System consists of 21 red visible light, diode lasers and 30 red light super-luminescent diodes configured within an outer helmet and protective inner. The use of diode lasers and non-laser LEDs provides for a full coverage of the upper 1/3 of the head; i.e., the area commonly covered with stylized hair. The helmet system will automatically pause therapy if the subject's head is moved outside of the zone of radiation and will resume therapy when the correct head position is re-established. At the end of the therapy cycle, the system signals that therapy is complete and ready to be powered down, by emitting an audible beep pattern.
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