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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: HQF FDA class 2

    Laser, Ophthalmic

    Ophthalmic

    View full classification →

    An Ophthalmic Laser is a surgical device that uses focused laser energy for a range of ophthalmic applications including retinal photocoagulation, glaucoma treatment (laser trabeculoplasty or iridotomy), posterior capsulotomy, and refractive procedures. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HQF and is regulated under 21 CFR 886.4390, within the Ophthalmic medical specialty. It is eligible for third-party review.

    510(k) Clearances

    50+ matches
    K Number
    Device Name
    EyeQ nanoECP
    Leos Laser and Endoscopy System
    LYNX Photocoagulator
    VISULAS combi
    MR Q; MR Q SUPINE; MR Q SLT
    Eagle device
    VISULAS green
    VISULAS yag
    Merilas 532 shortpulse, Merilas 577 shortpulse, Merilas 810 shortpulse
    Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)
    R:GEN
    Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
    Tango Neo, Tango Reflex Neo, Ultra Q Reflex Neo
    ECHO Photocoagulator
    Selecta Duet LED, Digital Duet, Selecta LED Trio, Digital Trio Laser Systems
    Capsulo
    Iridex 810 Laser
    Tango, Tango Reflex, Ultra Q, Ultra Q Reflex, Solo
    Ophthalmic Yag Laser System YC-200
    Iridex 810 Laser
    LION Photocoagulator
    Vitra 810
    Ophthalmic Yag Laser System YC-200
    LightLas Pattern Scanning System - TruScan Pro
    Leaf Photocoagulator
    VISULAS green
    PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar
    PSLT for PASCAL Streamline
    Easyret
    YELLOW LASER PHOTOCOAGULATOR YLC-500
    R:GEN Laser System
    LightLas Multi-Wavelength Medical Laser System
    Green Laser Photocoagulator GYC-500
    Integre Pro Scan Green, Integre Pro Scan Yellow, Integre Pro Scan Red-Green, Integre Pro Scan Red-Yellow
    Ophthalmed Bending Laser Probes
    LIGHTMED TRUSCAN 577
    FIBERION OPHTHALMIC ENDOLASER PROBE
    KATALYST REVOLVER LASER PROBES, KATALYST REVOLVER ILLUMINATED LASER PROBES, KATALYST REVOLVER ILLUMINATED PROBES
    NIDEK MULTICOLOR LASER PHOTOCOAGULATOR SYSTEM MC-500 CONNECTED WITH THE ENDOPHOTOCOAGULATION DELIVERY UNIT
    OPTIMUS FUSION: SLT, YAG AND YAG/SLT
    SCANNING LASERLINK
    FEMTO LDV(TM) Z-GENERATION FEMTOSECOND SURGICAL LASER
    LIGHTLAS FAMILY OF MULTI-WAVELENGTH MEDICAL LASER SYSTEM
    SOLUTIS
    ELLEX 2RT
    PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER
    PASCAL LASER INDIRECT OPHTHALMOSCOPE
    KATALYST LASER PROBES, KATALYST ILLUMINATED LASER PROBES
    SUPRA SCAN DELIVERY SYSTEM
    OPTO HYALUS GREEN 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.

    Popular Product Codes

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