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

    THERMAPULSE

    K Number: K092222 · Decision Aug 20, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    462
    Registration Numbers
    462
    Same Product Code
    228
    Applicant Total
    21
    Review Days
    28

    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
    THERMAPULSE
    K Number
    K092222
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    890.5500
    Medical Specialty
    Physical Medicine
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Palomar Medical Products, Inc.
    Date Received
    July 23, 2009
    Decision Date
    August 20, 2009
    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 Products, Inc.

    K Number Device Name
    K111840 EMERGE FRACTIONAL LASER
    K091446 MODIFICATION TO LUX1540 HANDPIECE AND LUX 1440 HANDPIECE
    K090525 LOI SYSTEM
    K083900 ERBIUM FRACTIONAL HANDPIECE
    K083165 PALOMAR ASPIRE LASER PLATFORM
    K080244 PALOMAR LUX 1540 HANDPIECE
    K081416 PALOMAR ASPIRE LASER PLATFORM
    K080567 PALOMAR ASPIRE LASER PLATFORM
    K073583 MODIFICATION TO PALOMAR LUX1540 HANDPIECE
    K071768 ERBIUM FRACTIONAL HANDPIECE
    Search all 21 clearances from Palomar Medical Products, Inc. →