BEUDAMED
    Tool · 510(k)

    510(k) Predicate Finder

    Find potential predicate devices for your 510(k) submission. Enter a K-number to find all clearances with the same product code, a three-letter product code to browse clearances directly, or search by device name.

    Product Code: OHS FDA class 2

    Light Based Over The Counter Wrinkle Reduction

    General, Plastic Surgery

    View full classification →

    The Light Based Over The Counter Wrinkle Reduction device uses light-based energy to reduce wrinkles on the body or specific anatomical locations, intended for consumer self-use without a prescription. Classified as FDA Class 2 under regulation 21 CFR 878.4810 within the General, Plastic Surgery medical specialty, it requires a 510(k) premarket notification demonstrating substantial equivalence to a predicate device. The product code is OHS. It is not flagged as an implant or life-sustaining device.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    KALA Therapy Wand (Model: KALA-03)
    CurrentBody Skin™ LED Light Therapy Mask Series 2 (MK-90H)
    LED Facial Mask
    LED LIGHT MASK (A093)
    LED Light Therapy Mask (G15, G15P, G15K, G11P, G11, G10, G13, G14, G17, VISO, PRANA, Chin2Chest, BBL-FACEMASK)
    Light Therapy System (M500, L6)
    Solawave 2-in-1 Skincare Mini (Model: 61043)
    Wrinkle Treatment Device (JM1, JM2B)
    Radiant Renewal Skincare Wand (HD-44,HD-44A ,HD-44B,HD-44C, HD-69, HD-69A, HD-69B)
    LED Therapy Mask (MN1, M226)
    LMNT O2
    Aglaia LED Beauty Device (BP-D2309)
    EnergyLounger (TY-01)
    LYMA Laser PRO
    CurrentBody™ LED 4 in 1 Zone Facial Mapping Mask (MK-90C, MK-90M, MK66RB-F, MK-90N)
    LED Light Therapy Mask (Model(s): RB-008, RB-030, RB-081, RB-008G, RB-008GB, RB-008J, RB-008JB)
    Ulike Reglow Light Therapy Device (UM10)
    Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)
    LED Light Therapy Mask (SKB-1818P,SKB-1918,SKB-1918P,SKB-1918PLUS,SKB-2318L,SKB-2318P,SKB-2318PRO,IN-FM002, SKB-2418)
    Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-59C, HD-59D, HD-70, HD-72, HD-72A, HD-73A, HD-73B, HD-116, HD-116A, HD-53A, HD-53B)
    LED Light Therapy Machine (G1, G3, G4, G6)
    CryoGlow (FW3XXXX)
    décoLITE LED Device
    Micro-current Facial Beauty Device (AM-810B, AM-810W, AM-812B, AM-812W)
    LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)
    HIGHERDOSE Red and Infrared Light Mask (MK66-L)
    Luna 4 plus
    PMD Clean Redvolution (4005-moab-NA, 4005-moab-INT, 4005-pepper-NA, 4005-pepper-INT, 4005-cream-NA, 4005-cream-INT, 4005-twilight-NA , 4005-twilight-INT, 4005-grey-NA, 4005-grey- INT)
    FAQ™ 201, FAQ™ 202
    Face Patches (MT-12MA, MT-12MC)
    Wrinkle Treatment Device (JM2)
    NUNA LUX (NUNL528)
    LED silicone mask (Model: LP-RVTGLWP-WHT, LP-RVTGLW-WHT, TLM200)
    LED Eye mask (EY-20R, A20, EY-20N)
    Radiant Renewal Skincare Wand (HD-15, HD-15A)
    Led Mask Platinum Exclusive MD
    B.Light Clear Evo and B.Light Restore Evo
    LUMA LED patches (LUMA Blemish (TN2197) and LUMA Revive (TN2189))
    TheraFace Mask
    Infrared Heat (Model: E0221)
    myLEDmask
    LED Facial Mask
    Q-Rejuvalight Pro Facewear (Model: P19-0023)
    LUSTRE ClearSkin Renew Pro Facewear Mask(Model: PR4001)
    LED light therapy mask (FM-01, FM-02, FM-03)
    NIRA Model 2
    reVive Light Therapy® Wrinkle and Acne LED Device
    LED Light Therapy Mask (model: MK-78, MK-04, MK66-H, MK66R-B, EL00003)
    LED Eye Perfector, model: EY-36A, EY-36B
    LED Light Therapy Mask (model: MK66R-B)

    What is a Predicate Device?

    A predicate device is a legally marketed device that a new 510(k) applicant uses to demonstrate substantial equivalence. The FDA's 510(k) pathway requires manufacturers to show that their device has the same intended use and similar technological characteristics as one or more predicate devices already cleared for commercial distribution.

    Finding the right predicate is a critical step in 510(k) strategy. Manufacturers typically search for cleared devices with the same FDA product code, which groups devices by their intended use and regulatory classification. This tool helps you identify potential predicates by browsing all clearances within a product code.

    Note that predicate devices must be legally marketed — they cannot be devices that were cleared but never commercialized, or devices subject to a mandatory recall. The determination of substantial equivalence considers intended use, technological characteristics, and performance data.

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