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.
Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption
General, Plastic Surgery
The Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption is a non-invasive aesthetic device that uses focused ultrasound to produce localized mechanical motion within tissues and cells, resulting in either tissue coagulation through localized heating or mechanical disruption of cellular membranes. Classified as FDA Class 2 under regulation 21 CFR 878.4590 within the General, Plastic Surgery medical specialty, it requires a 510(k) premarket notification. The product code is OHV. It is not flagged as an implant or life-sustaining device.
510(k) Clearances
29 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.