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510(k) Data Aggregation

    K Number
    K111840
    Device Name
    EMERGE FRACTIONAL LASER
    Manufacturer
    PALOMAR MEDICAL PRODUCTS, INC.
    Date Cleared
    2011-11-14

    (138 days)

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

    PALOMAR MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Emerge Fractional Laser is intended for use in dermatological procedures requiring coagulation of soft tissue and skin resurfacing procedures. The Emerge Fractional Laser is further indicated for treatment of pigmented lesions, such as, but not limited to lentigos (age spots), solar lentigos (sun spots), melasma, dyschromia, and for treatment of facial wrinkles and fine lines.
    Device Description
    The Emerge Fractional Laser consists of a fractional laser handpiece attached to a base unit. The base unit includes a power supply, control electronics, and user interface LCD screen.
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    K Number
    K091446
    Device Name
    MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE
    Manufacturer
    PALOMAR MEDICAL PRODUCTS, INC.
    Date Cleared
    2009-10-27

    (165 days)

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

    PALOMAR MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Palomar Lux1540 handpiece is intended for use in dermatological procedures requiring: coagulation of soft tissue, skin resurfacing procedures, melasma, acne scars, and surgical scars. The Palomar Lux1440 handpiece is intended for use in dermatological procedures requiring: coagulation of soft tissue and skin resurfacing procedures.
    Device Description
    The Lux1540 Handpiece & Lux1440 Handpiece each attach to the StarLux Pulsed Light and Laser Systems. The complete StarLux System console consists of a power supply, chiller, electronics, portable cart, and a footswitch.
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    K Number
    K092222
    Device Name
    THERMAPULSE
    Manufacturer
    PALOMAR MEDICAL PRODUCTS, INC.
    Date Cleared
    2009-08-20

    (28 days)

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

    PALOMAR MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Power settings in the range of 5-50 Watts is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the ThermaPulse may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
    Device Description
    Not Found
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    K Number
    K090525
    Device Name
    LOI SYSTEM
    Manufacturer
    PALOMAR MEDICAL PRODUCTS, INC.
    Date Cleared
    2009-06-01

    (95 days)

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

    PALOMAR MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LOI System is an over-the-counter device intended for treatment of periorbital wrinkles.
    Device Description
    The LOI System is composed of a handpiece, base, power cord, charger, and pretreatment gel.
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    K Number
    K083900
    Device Name
    ERBIUM FRACTIONAL HANDPIECE
    Manufacturer
    PALOMAR MEDICAL PRODUCTS, INC.
    Date Cleared
    2009-02-27

    (60 days)

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

    PALOMAR MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Erbium Fractional Handpiece is intended for use in dermatological procedures requiring coagulation, resurfacing, and ablation of soft tissue. Procedures include skin resurfacing and treatment of wrinkles, rhytides, furrows, fine lines, textural irregularities, pigmented lesions, and vascular dyschromia.
    Device Description
    The Erbium Fractional Handpiece attaches to the StarLux Pulsed Light and Laser Systems. The complete system consists of a cart, system console, chiller, a footswitch, and a handpiece.
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    K Number
    K083165
    Device Name
    PALOMAR ASPIRE LASER PLATFORM
    Manufacturer
    PALOMAR MEDICAL PRODUCTS, INC.
    Date Cleared
    2009-02-13

    (109 days)

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

    PALOMAR MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Palomar Aspire™ Laser Platform is intended for coagulation of soft tissue. All soft tissue is included, such as skin, cutaneous tissue, and subcutaneous tissue. The device is further indicated for laser assisted lipolysis.
    Device Description
    The Palomar Aspire™ Laser Platform is a small transportable system which includes a cart, power supply, software, user interface panel, footswitch, cooling system and handpiece.
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    K Number
    K080244
    Device Name
    PALOMAR LUX 1540 HANDPIECE
    Manufacturer
    PALOMAR MEDICAL PRODUCTS, INC.
    Date Cleared
    2008-06-20

    (141 days)

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

    PALOMAR MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Palomar Lux1540 handpiece is intended for use in dermatological procedures requiring: Coagulation of soft tissue, skin resurfacing procedures, melasma, acne scars, and surgical scars.
    Device Description
    The Lux1540 Handpiece attaches to the StarLux Pulsed Light and Laser Systems. The complete system consists of a cart, system console, chiller, a footswitch, and a handpiece.
    Ask a Question
    K Number
    K081416
    Device Name
    PALOMAR ASPIRE LASER PLATFORM
    Manufacturer
    PALOMAR MEDICAL PRODUCTS, INC.
    Date Cleared
    2008-05-29

    (9 days)

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

    PALOMAR MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Palomar Aspire™ Laser Platform is indicated for laser assisted lipolysis.
    Device Description
    The Palomar Aspire™ Laser Platform is a small transportable system which includes a cart, power supply, software, user interface panel, footswitch, cooling system and handpiece.
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    K Number
    K080567
    Device Name
    PALOMAR ASPIRE LASER PLATFORM
    Manufacturer
    PALOMAR MEDICAL PRODUCTS, INC.
    Date Cleared
    2008-04-16

    (47 days)

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

    PALOMAR MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Palomar Aspire™ Laser Platform is indicated for laser assisted lipolysis.
    Device Description
    The Palomar Aspire™ Laser Platform is a small transportable system which includes a cart, power supply, software, user interface panel, footswitch, cooling system and handpiece.
    Ask a Question
    K Number
    K073583
    Device Name
    MODIFICATION TO PALOMAR LUX1540 HANDPIECE
    Manufacturer
    PALOMAR MEDICAL PRODUCTS, INC.
    Date Cleared
    2008-03-26

    (97 days)

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

    PALOMAR MEDICAL PRODUCTS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Dermatological procedures requiring the coagulation of soft tissue; Skin resurfacing procedures.
    Device Description
    The Palomar Lux1440 Handpiece attaches to the StarLux Pulsed Light and Laser System. The complete system consists of a cart, base unit, chiller, a footswitch, and a handpiece.
    Ask a Question

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