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.
Forensics Laser
Unknown
The Forensics Laser is an ultraviolet wavelength laser product used in forensic investigations for fingerprint detection and other forensic evidence visualization purposes. It is classified as FDA Not Classified (Class N) with product code RGG and is GMP-exempt. This product has no associated regulation number or medical specialty, as it is used in law enforcement and scientific forensic contexts. No implant or life-sustaining flags are present. The FDA regulates this product under electronic product radiation control provisions for laser-emitting devices.
No 510(k) clearances found for "RGG". 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.