BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    PALOMAR LUXIR HANDPIECE

    K Number: K050370 · Decision Jun 15, 2005
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    24
    Review Days
    121

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    PALOMAR LUXIR HANDPIECE
    K Number
    K050370
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Palomar Medical Technologies, Inc.
    Date Received
    February 14, 2005
    Decision Date
    June 15, 2005
    Product Code
    ILY
    Advisory Committee
    Physical Medicine
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    ILY Lamp, Infrared, Therapeutic Heating

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (ILY), ordered by most recent decision date.

    CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight F2-B30; CureLight F3-AB30; CureLight F3-AB60.)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    LED Lip Perfector, model: ZC-05

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    OLIZ LTB-1000A

    FDA 510(k)
    FDA Class 2 ·Physical Medicine

    CytonPro-5000

    FDA 510(k)
    FDA Class 2 ·Physical Medicine
    View all

    Other Clearances by Palomar Medical Technologies, Inc.

    K Number Device Name
    K130250 QYAG LASER SYSTEM
    K120622 PALOMAR VECTUS LASER
    K110907 PALOMAR ICON (TM) AESTHETIC SYSTEM
    K103664 PRIMUS AESTHETIC PLATFORM
    K101506 LUX1540, LUX1440 & LUX2940 LASER HANDPIECES
    K100270 ARTISAN AESTHETIC SYSTEM
    K090195 PALOMAR LUX1540 HANDPIECE
    K070298 MODIFICATION TO PALOMAR LUXIR HANDPIECE
    K063571 PALOMAR LUX2940 HANDPIECE
    K060839 ABC HAIR REMOVAL SYSTEM
    Search all 24 clearances from Palomar Medical Technologies, Inc. →