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    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: OAP FDA class 2

    Laser, Comb, Hair

    Physical Medicine

    View full classification →

    The Laser, Comb, Hair (product code OAP) is a low-level laser therapy device in comb form intended to promote hair growth in males with androgenic alopecia classified as Norwood-Hamilton class IIa to V. It is classified as FDA Class 2, requiring 510(k) clearance, and is regulated under 21 CFR 890.5500 within the Physical Medicine specialty. The device carries no implant or life-sustaining flags.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Laser Hair Growth Device (F21151, F21152, F21153, F21154, F21155, F21156, F21157, F21158, F21159)
    Laser Hair Growth System (Laser Cap 128, Laser Helmet 272, Laser Helmet 352, Laser Helmet 552, Laser Helmet 500)
    Alma TED+ System
    TRUDERMAL HALO HAIR GROWTH SYSTEM (M-180A); ADURO HAIR GROWTH (M-130,M-300)
    Hair Regrowth Cap (Model: T-119-HRC)
    Q-Renew LLLT Hair Growth Helmet (Q-HLMT-V1)
    Hair Growth Laser Cap
    CurrentBody Skin Dual Light Hair Growth Helmet (model: MZ-07A)
    Red Light Hair Growth Cap (LP-RJVGRW-BLK)
    Hair Growth Device (KCA441-200, KCA441-120, KCA441-88, KCA441-56, KCA441-200S, KCA441-120S, KCA441-88S, KCA441-56S, KCA451-200, KCA451-120, KCA451-88, KCA451-56, KCA451-200S, KCA451-120S, KCA451-88S, KCA451-56S)
    FAQ™ (302)
    GroWell BT Hair Growth System (GW10042)
    HIGHERDOSE Red Light Hat (HG-120K)
    Hair Growth Comb (SZ-23,SZ-23A)
    Breo Laser Hair Growth Comb (Scalp 3L)
    PBM Hair Therapy Cap
    Robin's Egg
    Revian Lyte (10011)
    Bosley Booster 128 Laser Cap; Bosley Booster 162 Laser Cap; Bosley Booster 288 Laser Cap
    Hair Boom Air / Ulike Hair UpUp / Hair Boom 69 / Hair Boom
    Laser Cap, Model: Hat-01
    Nooance Led And Laser Helmet
    Neuhat Hair Growth System; ibeauty.com Laser Cap
    F65 Laser System
    Laser Therapy Hair Growth Comb, Model: Lasercomb-001 & Lasercomb-002
    Hair Boom 69, Hair BoomAir, Hair Boom, Ulike Hair UpUp
    Aduro Comb (Model: SZ-22, SZ-22A, SZ-22B)
    CurrentBody Skin™ Led Hair Regrowth(Model: MZ-07)
    Hair Growth Device
    Xtrallux Alpha (XA136R-USA), Xtrallux Super Plus (XS276R-USA/XS276L-USA), Xtrallux Turbo Pro (XP316R-USA), Xtrallux Extreme RX (XR352R-USA)
    ID-510 iRestore Elite
    Intelligence LaserComb
    Laser Hair Growth Comb
    Laser hair growth helmet
    Auxo A300, A150 and APod
    LLLT Laser Hair Growth Cap, Model: Hair Care 88, Hair Care 135, Hair Care 210.
    ID-500 iRestore Hair Growth System
    Grivamax Family of Lasers, Models 272 and 148
    Biophotas Celluma RESTORE
    Hair Growth Device
    LaserCap Family of Lasers 300, 224, 120 & 80
    easy Hairfull
    iHelmet Laser Comb
    Tricoglam Home Use
    CAPOGEN Laser Cap
    LG Pra. L Derma LD Scalp Care
    Hair Growth System
    Irradiation Cosmetic Device
    Shapiro MD model laser 272
    Bosley Revitalizer 96 Laser Cap, Bosley Revitalizer 96 XL Laser Cap

    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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