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

    SHASER IPL HAIR REMOVAL SYSTEM

    K Number: K103560 · Decision May 18, 2011
    View on FDA
    Classifications
    1
    FEI Numbers
    92
    Registration Numbers
    93
    Same Product Code
    73
    Applicant Total
    10
    Review Days
    166

    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
    SHASER IPL HAIR REMOVAL SYSTEM
    K Number
    K103560
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Shaser, Inc.
    Date Received
    December 3, 2010
    Decision Date
    May 18, 2011
    Product Code
    ONF
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect

    Similar 510(k) Clearances

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

    Intense Pulsed Light Therapy Device

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Intense Pulsed Light Therapy Device (MMABM-1)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    MEDILIGHT

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    IPL Treatment Device (MDSQMC-01)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    DEKA LOTUS

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Intense Pulsed Light Treatment System (LK-PT)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Shaser, Inc.

    K Number Device Name
    K150282 Shaser Skin Beauty Intense Pulsed Light System Family for Acne
    K142924 Shaser Skin Beauty SkinREJUV Intense, Pulsed Light System Family
    K141583 SHASER SKIN BEAUTY INTENSE PULSED LIGHT SYSTEM FAMILY
    K140631 LUMENA FH HAIR REMOVAL SYSTEM
    K133201 SHASER V-MINI 2 HAIR REMOVAL SYSTEM
    K132170 SHASER V-MINI RX
    K132266 SHASER HRS2 RX HAIR REMOVAL SYSTEM
    K130015 SHASER V-MINI HAIR REMOVAL SYSTEM
    K120080 SHASER HRS2 HAIR REMOVAL SYSTEM