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Duetto Suprema - Suprema 4V

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K223404

by Quanta System Spa

Identifiers

510(k) Number
K223404 FDA 510(k)
FDA Product Code
GEX FDA 510(k)
Models / Variants
Duetto Suprema FDA 510(k)EUDAMED
Domino Suprema FDA 510(k)EUDAMED
Suprema VT FDA 510(k)EUDAMED
Suprema VT+ FDA 510(k)EUDAMED
Suprema 4V FDA 510(k)EUDAMED

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4810 FDA 510(k)
Regulation Number
878.4810 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Suprema VT, Suprema VT+, Suprema 4V, Duetto Suprema, and Domino Suprema are Class II laser surgical instruments classified under 21 CFR 878.4810 for use in general and plastic surgery, as well as dermatology. These devices are designed for precise tissue ablation, coagulation, and vaporisation using laser technology, catering to procedures requiring controlled energy delivery in soft tissue applications.

These instruments are supplied as reusable medical devices, intended for use in sterile surgical environments. They comply with FDA 510(k) clearance (K223404) and the EU Medical Device Directive (MDD), with regulatory submissions filed under the General, Plastic Surgery advisory committee. Models include distinct configurations (e.g., VT+, 4V) for varying clinical requirements, and storage must adhere to manufacturer guidelines for maintenance and sterilisation.

Frequently asked questions

Are these devices single-use or reusable, and what does that mean for my facility’s workflow?

The Suprema VT, VT+, 4V, Duetto Suprema, and Domino Suprema are reusable medical devices, meaning they are designed for repeated use after proper cleaning, maintenance, and sterilization. This requires your facility to follow the manufacturer’s guidelines for sterilization (e.g., autoclave or chemical sterilization) and maintenance protocols to ensure safety and performance. Reusability reduces waste but demands adherence to strict infection control procedures.

What types of surgical procedures are these devices intended for, and how do the different models differ?

These devices are classified under 21 CFR 878.4810 for general, plastic surgery, and dermatology procedures, specifically for precise tissue ablation, coagulation, and vaporization using laser technology. The models (VT+, 4V, Duetto, Domino) offer distinct configurations tailored to varying clinical needs—likely differing in handpiece design, energy settings, or fiber optics—but exact procedural applications are not specified beyond soft tissue applications. Check the manufacturer’s documentation for model-specific use cases.

How should I store these devices when not in use to maintain their performance and sterility?

Storage must follow the manufacturer’s guidelines to preserve sterility and functionality. Since these are reusable, they should be stored in a clean, dry environment (e.g., sealed packaging or sterilization pouches) until ready for reprocessing. Avoid exposure to moisture, extreme temperatures, or contamination. The manufacturer’s instructions will specify any additional precautions, such as protective cases or shelf-life considerations for sterilized units.

What regulatory pathways have these devices undergone, and how does that affect their use in my country?

These devices hold FDA 510(k) clearance (K223404) under the Special 510(k) pathway and comply with the EU Medical Device Directive (MDD). The FDA clearance indicates they are deemed substantially equivalent to a predicate device, while MDD compliance ensures they meet EU safety and performance standards. For use outside the U.S. or EU, verify local regulatory requirements, as equivalence to these clearances may not automatically apply elsewhere.

Are there different sizes or models available, and how do I determine which one is right for my practice?

The Suprema VT, VT+, 4V, Duetto, and Domino models represent distinct configurations, likely differing in handpiece design, fiber optics, or energy delivery profiles to suit specific surgical needs (e.g., depth of penetration, tissue type, or procedural precision). The exact sizing or model selection criteria (e.g., for fine detail vs. broader coagulation) aren’t detailed here, but the advisory committee filing under

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: Hotel revenue management software & solutions | Duetto, Duetto Suprema; Domino Suprema; Suprema VT; Suprema VT+; Suprema 4V, PDF Quanta System, S.p.A. Dario Bandiera Regulatory Affairs Manager Via ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

United States Active

FDA_510K

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Manufacturer

Manufacturer
Quanta System Spa

Sources (2)

  • FDA 510(k) K223404 24 fields · synced Oct 6, 2026
  • EUDAMED 1 fields · synced May 19, 2026