Lutronic Genius Radiofrequency System
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K180945 FDA 510(k)
- FDA Product Code
- GEI FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Lutronic Genius Radiofrequency System is a radiofrequency device intended for electrocoagulation and hemostasis in dermatologic and general surgical procedures. It delivers controlled radiofrequency energy, often via microneedles, to achieve tissue coagulation and promote skin remodeling.
The system is supplied as a complete radiofrequency platform and is cleared in the United States under FDA 510(k) traditional clearance (K180945) as substantially equivalent to a predicate device. It is regulated as a medical device and is used in clinical settings according to the manufacturer’s instructions.
Frequently asked questions
What clinical applications is the LUTRONIC GENIUS Radiofrequency System designed for?
The system is intended for electrocoagulation and hemostasis during dermatologic and general surgical procedures. By delivering precise radiofrequency energy, it can coagulate tissue, control bleeding, and support skin remodeling, making it useful for both plastic surgery and broader operative settings.
How is the device supplied and what components are included?
The LUTRONIC GENIUS is provided as a complete radiofrequency platform, meaning the main console, power source, control software, and compatible accessories such as microneedle electrodes are all packaged together. This turnkey configuration ensures clinicians have everything needed for immediate clinical use without separate purchases.
Is the system single‑use or reusable, and what are the sterility considerations?
The platform itself is a reusable medical device, designed for repeated clinical use following proper cleaning and disinfection per the manufacturer’s instructions. Disposable accessories, such as microneedle tips, are typically supplied sterile and intended for single‑use to maintain patient safety and prevent cross‑contamination.
What regulatory pathway was used for clearance of this device in the United States?
The LUTRONIC GENIUS Radiofrequency System received traditional 510(k) clearance (K180945) from the FDA, indicating it was found substantially equivalent to a legally marketed predicate device. This pathway confirms the system meets the necessary safety and performance standards for its intended uses.
How should the system be stored before use?
The device should be stored in a clean, dry environment at room temperature, protected from extreme temperatures, humidity, and direct sunlight. Accessories that are supplied sterile should remain in their original packaging until the point of use to preserve sterility.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Genius RF Microneedling - Cynosure Lutronic, Genius - Cynosure Lutronic EMEA Genius RF Microneedling, [PDF] December Lutronic Corporation James Childs, Ph.D. Clinical ..., Lutronic Genius RF for Sale | RF Microneedling System
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K180945 | Class II | Active |
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Manufacturer
- Manufacturer
- Lutronic Corporation
Sources (1)
- FDA 510(k) K180945 24 fields · synced Sep 25, 2026