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Thunder, Thunder VT, Thunder HR

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K171711

by Quanta System Spa

Identifiers

510(k) Number
K171711 FDA 510(k)
FDA Product Code
GEX FDA 510(k)

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 Thunder, Thunder VT, and Thunder HR are electrosurgical generators designed for precise tissue dissection and coagulation in surgical procedures. These devices deliver controlled radiofrequency energy to facilitate cutting and sealing of soft tissues, enhancing surgical efficiency and reducing blood loss during procedures such as plastic surgery.

These devices are supplied as reusable medical equipment, intended for use in operating room settings. They are not sterile upon receipt and require proper cleaning, disinfection, and sterilization before use. The Thunder series is classified under product code GEX and holds FDA 510(k) clearance and MDD authorization, adhering to regulatory standards for electrosurgical devices. Storage and handling must comply with manufacturer guidelines to ensure safety and functionality.

Frequently asked questions

Are the Thunder series devices meant for single-use or can they be reused in multiple procedures?

The Thunder, Thunder VT, and Thunder HR are designed as reusable medical equipment. Since they are not sterile upon receipt, they require thorough cleaning, disinfection, and sterilization between uses to maintain safety and functionality. This process aligns with standard operating room protocols for reusable electrosurgical generators.

What types of surgical procedures are these devices primarily intended for, based on their design and regulatory classification?

While the product code (GEX) and advisory committee classification (General, Plastic Surgery) suggest a focus on general and plastic surgery applications, the devices are not intended for specific clinical uses beyond what’s stated in the description. They are electrosurgical generators for precise tissue dissection and coagulation, which can be applied broadly in procedures where controlled radiofrequency energy improves efficiency and reduces blood loss.

How should these devices be stored to ensure they remain functional and safe for reuse?

The Thunder series must be stored and handled strictly according to the manufacturer’s guidelines (Quanta System Spa). Since they are reusable, proper storage conditions—such as protection from moisture, dust, and physical damage—are critical. The devices should also be kept in a clean, dry environment to prevent degradation before sterilization for subsequent use.

What regulatory pathways have these devices undergone, and what does that mean for their use in clinical settings?

The Thunder series holds FDA 510(k) clearance (K171711) and MDD authorization, confirming compliance with U.S. and European regulatory standards for electrosurgical generators. This means they meet established safety and performance requirements for use in operating rooms, but clinicians should always follow local institutional protocols and the manufacturer’s instructions for proper operation, maintenance, and sterilization.

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.

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) K171711 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026