Regulatory

Intended use & professional-use requirements.

How the 4th State Fusion platform is intended to be used, who may operate it, and how availability and claims vary by market.

Professional-use only

4th State Fusion, CAP, and Fusion Jet are professional aesthetic devices intended for use by licensed or trained providers in accordance with applicable laws and manufacturer training. They are not for home or consumer use.

Market-specific availability and claims

Device availability, indications, claims, and regulatory status vary by market. Statements on this website are informational and are not a substitute for the product labeling, training, and clinical guidance provided at the time of purchase and onboarding in your region.

Intellectual property

Two 4th State Fusion devices are currently patent pending, and a third device patent application is in preparation. Nothing on this page grants or implies any license to Regenera Holdings LLC patents, trademarks, or other intellectual property.

Training requirement

Operators must complete the required provider training before treating patients. Structured training, protocols, and clinical support are included with device purchase.

Not medical advice

Information on this website is for professional and educational purposes only and is not medical advice, diagnosis, or a treatment recommendation. Individual results vary.

Reporting

Providers should report device concerns or adverse events to Regenera Holdings LLC at greg@diametrics.ai, in addition to any locally required regulatory reporting.

Take the next step

Bring 4th State Fusion into your practice.

Speak with our device team about the flagship 4th State Fusion platform, CAP, and Fusion Jet — and how they fit your treatment menu.