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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: GEX FDA class 2

    Powered Laser Surgical Instrument

    General, Plastic Surgery

    View full classification →

    The Powered Laser Surgical Instrument (product code GEX) is a laser-based device that uses coherent, collimated, and typically monochromatic radiation to cut, destroy, remove, or coagulate tissue in general and plastic surgery, as well as related specialties including dermatology, podiatry, otolaryngology, gynecology, neurosurgery, orthopedics, dental and oral surgery. The underlying classification regulation (21 CFR 878.4810) addresses carbon dioxide or argon lasers intended for tissue cutting and coagulation. This device is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket notification; it is also eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)
    PICOSURE WORKSTATION
    LumiGlam Laser System (SHE-LSP601-3)
    LASEmaR 1500
    LUNE PureHygiene
    Boston 2910 (Boston 2910)
    MOSES Raydar™
    PICO SHINING (PICO-K; PICOFY)
    CO2 Laser Machine (Monica-I,Monica-II)
    Q-Switched Nd: YAG Laser Systems
    Leaseir MHR Xcell (console) (MHR-100b); Handpiece: Dual (810-b and Blend-b); Handpiece: Quad (810-b and Blend-b)
    YellowStar
    VANISH PRO
    Q-Switched Nd: YAG Laser System (Glamor Q)
    Diode Laser Therapy Systems (V19)
    Picosecond Nd:YAG Laser Systems (Model: HS-298)
    Nd: YAG Laser Therapy Systems
    CO2 Laser System
    LASER THERMAL THERAPY KIT
    Elyra™ Thulium Fiber Laser System and Elyra™ Plus Thulium Fiber Laser System (Laser, Fibers, and Accessories)
    Picasso Pro Diode Laser (002-00460)
    Holmium Laser Therapeutic Apparatus (HZ-A); Holmium Laser Therapeutic Apparatus (HZ-B); Holmium Laser Therapeutic Apparatus (HZ-E)
    CO2 Laser Treatment Machine (CFR3M1)
    Medical Alexandrite and Nd:YAG laser Therapy System (CM11LP)
    Medical Ultra-Pico Laser Treatment System (CM-SP-1064&532)
    CAPRI
    Diode Laser Therapy Systems (WLA-02)
    BTL-754FF
    808nm semiconductor laser hair removal machine
    Boston PICO (Boston PICO)
    Vydence Family of Lasers
    Holmium Laser Therapeutic Apparatus (HZ-40)
    Boston Pico755
    PICO-K
    JOULE 1064nm System and Accessories
    SANDRO Dual
    CO2 Laser Therapy System (Model: LFS-D9U)
    Halo Sterile Single-use Radial Fiber (Halo-R-0.40-2.5/Halo-R-0.60-2.5/Novo-R-0.60-1.8/Novo-R-0.40-1.8)
    Medical Diode Laser Systems (TR-B)
    BELLUS-Q
    LeafPure-Echo (LM-LPNdA)
    Thulium Fiber Laser System (TFL-A); Thulium Fiber Laser System (TFL-B)
    Holmium Laser System (Potent HP90); Holmium Laser System (Potent HP100); Holmium Laser System (Potent HP9120); Holmium Laser System (Potent HP140); Holmium Laser System (Potent HP150)
    CuRAS hybrid
    Laser Fiber (PT-OF-A-S); Laser Fiber (PT-OF-B-S); Laser Fiber (PT-OF-C-S); Laser Fiber (PT-OF-D-S); Laser Fiber (PT-OF-E-S); Laser Fiber (PT-OF-F-S)
    Medical Diode Laser Systems (VeinCure)
    CO2 Laser Therapy System (K106)
    Q-Switched Nd:Yag laser (K690)
    Tamburo Thulium Fiber Laser System
    Diode Laser Hair Removal Machine (GLD01)

    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.

    Popular Product Codes

    Commonly searched
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