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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: HHR FDA class 2

    Laser, Surgical, Gynecologic

    Obstetrics/Gynecology

    View full classification →

    The Gynecologic Surgical Laser is a laser-based device used in gynecological surgery for tissue cutting, ablation, coagulation, or vaporization, applicable to procedures such as treatment of endometriosis, cervical lesions, or condyloma. It is classified as FDA Class 2 (moderate risk), requiring 510(k) premarket notification. The product code is HHR, regulated under 21 CFR 884.4550, within the Obstetrics/Gynecology specialty. It is eligible for third-party 510(k) review.

    510(k) Clearances

    48 matches
    K Number
    Device Name
    ENDOCOAGULATOR MODEL 20 LASER & ACCESSORIES
    MODEL 5050 SURGILASER FOR OB-GYN USE
    GL-35 COLPOSCOPIC LASER SYSTEM
    LASER CANNISTER FILTER
    LASEGUIDE 600A, 600B, 400A, 400B FOR OB-GYN USE
    MDLS 4000,4900,6000,8000,8900 ND:YAG/1700 C02 LASE
    LASER OPTICAL CATHETER SYSTEM
    MODEL 4900 ND:YAG LASER FOR ENDOMETRIAL ABLATION
    KTP/532 LASER FOR OB-GYN USE
    HERACURE LS 500
    MODEL 20-C, RL-20A/U, OB-10A/U
    MODEL 20-C W/BR-20A/U ATTACH/MODEL HL-3.0 OB/GYN
    ADVANCED HAND HELD CO2 LASER/HH-550 FOR DOED USE
    FIBERLASE II ND:YAG LASER FOR TREAT OF MENORRHAGIA
    SLT CONTACT ND:YAG LASER FOR INTRA-ABDOM.&GENITAL
    MODEL 2100 ND:YAG SURGICAL LASER GYNECOLOGICAL USE
    CONTACT ND:YAG LASER FOR TREATMENT OF MENORRHAGIA
    MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.
    CO2 LASER MICROMANIPULATOR
    DOUBLE PUNCTURE CO2 LASER LAPAROSCOPY SET
    OMNIPLUS PHOTOSURGICAL LASER SYSTEM FOR OB-GYN
    MODEL 8900 ND:YAG LASER, TREATMENT OF MENORRHAGIA
    SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE
    CO2 LASER MICROMANIPULATOR
    FIBERLASE 100 MEDICAL LASER SYS/ND:YAG MENORRHAGIA
    CABOT LASER LAPAROSCOPY ACCESSORY SET
    MODEL 8 & 20 ARGON LASER FOR PELVIC SURGERY IN GYN
    ND:YAG LASER 4000/6000/8000 ENDOMETRIAL ABLATION
    MODEL 8-B WITH LA-2B ATTACHMENT FOR OB-GYN USE
    ENDO-LASE CD40 CO2 FOR GYNECOLOGY
    ENDO-LSE CD-100 CO2 LASER FOR GYNECOLOGY
    MEDILAS 2 ND:YAG LASER SURGERY SYSTEM
    FYODOROV RADIAL KERATOTOMY MARKER SET
    PORTALASE 300 CARBON DIOXIDE SURG LASER GYNECOLOGI
    CO2 LASER LAPAROSCOPE SYSTEM
    MODEL J25-25 WATT CO2 LASER
    PORTALASE 200 CARBON SURGICAL LASER SYSTEM
    ABDOMINAL PRESSURE CONTROL VALVE
    YN CO2 LASER SYSTEM 30W
    CARBON DIOXIDE LASER ML 825
    MINUTEMAN CO2 MICROSURGICAL LASER GYN
    MONITOR CO2 LASER SYSTEM
    CARBON DIOXIDE (C02) MICROSURGICAL LASER
    CO2 LASER
    ML-800 CO2
    LASER, CO2 SURGICAL
    OB/GYN LASER, MODEL 920
    COLPOSCOPICALLY DIRECTED OB/GYN LASER

    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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