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.
Instrument, Visual Field, Laser
Ophthalmic
A Laser Visual Field Instrument is a diagnostic ophthalmic device that uses laser technology to present stimuli for automated visual field testing, enabling precise mapping of the patient's field of vision and detection of scotomas or defects associated with glaucoma, retinal, or neurological conditions. This device is FDA Class 2 (moderate risk), requiring premarket notification (510(k)) before marketing. It carries product code HPJ and is regulated under 21 CFR 886.1360, within the Ophthalmic medical specialty. It is eligible for third-party review.
510(k) Clearances
5 matchesWhat 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.