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.
Laser Pointer
Unknown
The Laser Pointer is a handheld laser product designed to indicate a specific point of interest, commonly used in presentations, education, and other settings where highlighting a location on a surface is needed. This product is classified as FDA Not Classified (Class N) with product code RES and is GMP-exempt. It has no associated regulation number or medical specialty, as it is a general consumer or commercial product rather than a medical device. No implant or life-sustaining flags are noted. Laser pointers are regulated by the FDA under the electronic product radiation control provisions rather than as medical devices.
No 510(k) clearances found for "RES". Try a different K-number, product code, or device name.
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.