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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
    AviClear Laser System
    Flexiva Pulse Laser Fiber; Flexiva Pulse TracTip Laser Fiber; Flexiva Pulse ID Laser Fiber; Flexiva Pulse ID TracTip Laser Fibers
    Pastelle
    SurgiLight 1470 Diode Laser System (Model:Halo)
    AuroLase® System
    Diode laser device (RF3120-BI)
    Optimas MAX System
    Fractional CO2 Laser Machine
    Deka Bluebeam
    Q-Switched Nd:YAG Laser (SHE-LSP101-1)
    CO2 Laser Machine (Lume)
    Nd: YAG Laser Therapy System (QN-1)
    Discovery Pico; Discovery Pico Plus; Discovery Pico Derm
    MateLaser Medical Laser Therapy Systems (ML-HIL-30, ML-HIL-60)
    The Alma Hybrid Laser System
    Medical Picosecond ND: YAG Laser System (PZ-6)
    Veincare
    Medical Diode Laser Hair Removal System (MNLT-D1)
    Alma Veil
    Diode laser hair removal machine (QDTM-02)
    CO2 Laser System (CO2 Laser SST-L23)
    Diode laser system (Night Universe; Predator)
    Stellar M22
    Alma Harmony
    Medical Diode Laser (Models: MZ-GK, MZ-K20, MZ-N75)
    Medical Diode Laser Systems (THEIA808)
    AdvaTx
    Medical Laser System Incanto / Evoline Platinum /Evoline
    Medical Diode Laser Systems (GBOX-6H, GBOX-10D , GBOX-12D, GBOX-15D, VELAS Pro-30B15D, VELAS II-6H, VELAS II-15D)
    Photon Therapy Apparatus (BL-10)
    neoLaser Laser Surgery Fibers
    PICOALEX
    NOABLE LASER
    Q Switched Nd:YAG Laser machine (QNHF-01)
    Medical diode laser systems (CHARISMA, REGAL)
    Single Use CO2 Laser Fiber (HAF005001)
    WONTECH Surgical Optic Fibers (BA400/BA400R/BA600/BA600R)
    Pastelle Pro
    HELIOS 785 Pico (1754V2)
    Diode Laser Hair Removal Device (EVOLUTION MEDICAL); Diode Laser Hair Removal Device (M-I-X MEDICAL); Diode Laser Hair Removal Device (GENESIS); Diode Laser Hair Removal Device (Lotus); Diode Laser Hair Removal Device (Ultimate)
    BTL-754
    CO2 Laser Therapy Systems (SHE-LSP003-1)
    Splendor X (Alex, Alex2, Nd:YAG, Alex+Nd:YAG)
    Diode Laser System model Dawn-S
    Diode Laser System (LaserPro D 980); Diode Laser System (LaserPro D 810); Diode Laser System (Aurolance 980); Diode Laser System (Aurolance 810); Diode Laser System (Aurolance AM)
    SLT Select Fiber Delivery System and Contact Tips (models: SSRH 8-SMA; TCRH 7-SMA; FEF 2.2-SMA; CFE 0.6-SMA; SSRH 8Z-SMA; SSRH 4-SMA; SSRH 6-SMA; SSRH 9-SMA; SSRH 10-SMA; SSRH 11-SMA; SSRH 7L-SMA; TCRH 7Z-SMA; FEF 1.8-SMA; CFE 0.55-SMA; CFE 0.36-SMA; LAL 550-SMA; LAL 550Z-SMA; LAL 365-SMA; LAL 365Z-SMA; ER2; ERP2; GR2; GRP2; ER4; ERP4; GR4; GRP4; ER6; ERP6; GR6; GRP6; ER8; ERP8; GR8; GRP8; ER10; ERP10; GR10; GRP10; ER12; ERP12; GR12; GRP12; MD2.5; MD3.5; HP1.0; MTP1.5; MTP3.5; MTRG1.5;
    LGO-Surgical Laser Fibers
    Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System (FG900-S2)
    HandPICO Fractional Laser Handpiece Tip
    Thulium Fiber Laser (FiberLAZE+, FiberLAZE)

    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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