BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇳🇱 Netherlands

    myLEDmask 2 (MJ-144)

    K Number: K260415 · Decision May 12, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    126
    Registration Numbers
    126
    Same Product Code
    152
    Applicant Total
    13
    Review Days
    92

    Basic Information

    Device Name
    myLEDmask 2 (MJ-144)
    K Number
    K260415
    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
    Light Tree Ventures Europe B.V.
    Date Received
    February 9, 2026
    Decision Date
    May 12, 2026
    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

    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

    Ulike Reglow Light Therapy Device (UM10)

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

    Other Clearances by Light Tree Ventures Europe B.V.

    K Number Device Name
    K253349 Hair Regrowth Cap (Model: T-119-HRC)
    K230720 LUSTRE 3XPRESS Light Beauty Therapy patches, model: PR6001, PR5001
    K223893 Infrared Heat (Model: E0221)
    K230597 Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
    K230042 Q-Rejuvalight Pro Facewear (Model: P19-0023)
    K230336 CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
    K230124 LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
    K223642 LED Lip Perfector, model: ZC-05
    K221775 LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
    K221444 LED Eye Perfector, model: EY-36A, EY-36B
    Search all 13 clearances from Light Tree Ventures Europe B.V. →