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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: LNK FDA class 2

    Laser For Gastro-Urology Use

    General, Plastic Surgery

    View full classification →

    Laser for Gastro-Urology Use is a laser surgical system applied in gastroenterological and urological procedures, such as fragmentation of urinary calculi (kidney stones), treatment of benign prostatic hyperplasia, ablation of bladder tumors, or treatment of gastrointestinal lesions. It is classified as FDA Class 2, indicating moderate risk, and requires 510(k) premarket clearance. The product code is LNK, regulated under 21 CFR 878.4810, within the General/Plastic Surgery medical specialty. This device is eligible for third-party 510(k) review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    TECHNOMED PULSOLITH 4000 LASER SYSTEM
    MDL-2000 LASERTRIPTER
    ND:YAG SURGICAL LASER FOR ENDO. GASTRO/URO. APPLI.
    ND:YAG SURGICAL LASER FOR GASTRO/UROLOGY APPLICA.
    MODEL 4060 N ND:YAG LASER FOR UROLOGICAL USE
    MODEL 4060 N ND:YAG LASER FOR GASTROENTEROLOGY USE
    ND:YAG 100 SURGICAL LASER FOR GASTRO. AND UROLOGY
    MODEL 4900 ND:YAG LASER FOR GASTRO & GENITOUR APPL
    MODEL 5050 SURGILASER FOR UROLOGY USE
    MODEL 5050 SURGILASER FOR GASTRO-INTESTINAL USE
    SURGI-LIGHT DISPOS.FIBEROPTIC DEL/SYS GI/URO USE
    KTP/532 LASER
    LASER OPTICAL FIBERS - DISPOSABLE
    SERIES 2900 SYNTHETIC CONTACT TIPS, GU USE
    ENDOCOAGULATOR(TM) MODEL 20 ARGON LASER FOR UROLO.
    FIBERLASE II ND:YAG LASER FOR GASTRO.&UROLOGY USE
    UNI-FIBER NON-REPAIRABLE FIBER DELIVERY SYSTEM
    SL-100 ND:YAG LASER FOR RECTAL PATHO. & HEMORRHOID
    SL-100 ND:YAG LASER FOR UROLOGIC SURGERY
    SL-100 ND:YAG LASER FOR GASTROINTESTINAL BLEEDING
    SL-100 ND:YAG LASER FOR PALLIATION OF GASTRO. MALI
    SHARPLAN MEDILAS MODEL 40 N FOR UROLOGICAL USE
    MODEL 20-C WITH AN SA-20A/U OPT. ATTACH. HEMORRHO.
    MODEL 20-C WITH AN SA-20B/U OPT. ATTACH. HEMORRHO.
    10-C/SA-10B/U OPT 20-C/20A/U BEAM SA-10B/U HEMORRH
    MODEL 10-C WITH AN SA-10A/U OPT. ATTACH. HEMORRHO.
    ADVANCED HAND HELD CO2 LASER/HH-550 FOR DGGD USE
    SINGLE USE LASER FIBER DELIVERY SYSTEM FOR ND: YAG
    CHANGE IN FIBERLASE 100 ND:YAG MEDICAL LASER
    LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM/SUPPLEM
    CONTACT TIPS
    ENDOSCOPIC ELECTROSURGICAL FIBEROPTIC PROBE
    OPTILASE YAG MODEL 1000 SURG LASER SYSTEM/GASTRO
    #6000 ND:YAG LASER SYSTEM UROLOGY/GASTROINTESTINAL
    MODEL 2100 ND:YAG SURGICAL LASER GASTROINTESTINAL
    MODEL 2100 ND:YAG SURGICAL LASER UROLOGICAL INDICA
    HGM, INC. LASERCATH (STERILE)
    MODEL NY-110 FOR UPPER & LOWER (GU) & PULMONARY
    S.L.T. CONTACT LASER SYSTEM
    S.L.T. CONTACT LASER
    S.L.T. LASER DELIVERY SYSTEM FOR YAG LASER
    MODEL 700 EVACUATOR FOR USE WITH LASER SURGERY
    ND:YAG LASER SINGLE USE FIBER DELIVERY SYSTEM
    FIBERLASE 100 ND: YAG MEDICAL LASER SYSTEM
    LASERSCOPE OMNI PLUS PHOTOSURGICAL SYSTEM
    HOTIP HEMOSTATIC PROBE
    FIBERLASE 100 MEDICAL LASER SYSTEM
    MODEL 4000 ND:YAG LASER FOR GASTROINTESTIONAL BLEE
    ND:YAG FIBERLASE 100 MEDICAL LASER SYSTEM
    ND. YAG LASER RECTAL PATHOLOGY

    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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