BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    Silk'n HST

    K Number: K162784 · Decision Mar 25, 2017
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    152
    Applicant Total
    15
    Review Days
    173

    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
    Silk'n HST
    K Number
    K162784
    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
    Home Skinovations , Ltd.
    Date Received
    October 3, 2016
    Decision Date
    March 25, 2017
    Product Code
    OHS
    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
    OHS Light Based Over The Counter Wrinkle Reduction

    Similar 510(k) Clearances

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

    LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K)

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

    LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H)

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

    CurrentBody Skin LED Multi Light Therapy Mask (MK-110D)

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

    myLEDmask 2 (MJ-144)

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

    LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)

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

    LED Light Therapy Masks (LumiLips FAC07NA)

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

    Other Clearances by Home Skinovations , Ltd.

    K Number Device Name
    K214078 Silk’n Toothwave
    DEN190039 ToothWave™
    K180279 Silk'n MODEL H5003 device
    K171433 Silk'n Infinity
    K152087 HeatLux Pro II
    K150175 HeatLux Pro I
    K141242 GLIDE DEVICE
    K131870 GLIDE DEVICE
    K121435 SILKN BLUE
    K120582 HEATLUX
    Search all 15 clearances from Home Skinovations , Ltd. →