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Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron 400 HP

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K220138

by Led Spa

Identifiers

510(k) Number
K220138 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 Surtron series comprises electrosurgical units designed for monopolar and bipolar surgical procedures, with the Surtron 80 D limited to monopolar use. These devices deliver controlled electrical energy for cutting, coagulation, and precision tissue management in surgical settings, supporting both general and plastic surgery applications. The units incorporate advanced features such as digital displays and microcontroller-based operation to enhance performance and safety.

Supplied as reusable medical devices, the Surtron units are intended for use in sterile surgical environments and comply with FDA 510(k) clearance and EU MDR authorisations. Models vary in power output, with the Surtron 80 D, 160, 200, Flash 160 HF, and 400 HP each offering distinct operational capabilities. Storage and handling follow standard electrosurgical equipment protocols, ensuring proper maintenance and sterility for repeated clinical use.

Frequently asked questions

What types of surgical procedures can the Surtron series be used for, and how does the power output vary between models?

The Surtron series is designed for monopolar and bipolar electrosurgical procedures, including cutting, coagulation, and precision tissue management, commonly used in general and plastic surgery. The power output varies by model: the Surtron 80 D is limited to monopolar use, while the Surtron 160, 200, Flash 160 HF, and 400 HP offer distinct operational capabilities tailored to different surgical demands. For example, the Surtron 400 HP provides higher power output compared to the lower-range models like the Surtron 80 D.

Are the Surtron units single-use or reusable, and what considerations should be taken for their maintenance and sterility?

The Surtron units are reusable medical devices, intended for use in sterile surgical environments. Since they are designed for repeated clinical use, proper maintenance and sterilization protocols must be followed to ensure safety and functionality. This includes regular cleaning, calibration, and adherence to standard electrosurgical equipment handling guidelines to maintain sterility and performance.

How do I determine which Surtron model is best suited for my surgical needs, given the different power outputs?

The Surtron series offers models with varying power outputs to accommodate different surgical requirements. For example, the Surtron 80 D is ideal for monopolar procedures requiring lower power, while the Surtron 400 HP is better suited for more demanding tasks. The Surtron Flash 160 HF and Surtron 200 provide intermediate options, balancing performance and precision. Consulting with your facility’s surgical team or reviewing the device specifications can help select the model that aligns with your specific procedural needs.

What regulatory approvals do the Surtron units hold, and how does this affect their use in clinical settings?

The Surtron series holds both FDA 510(k) clearance and EU MDR authorizations, confirming compliance with regulatory standards in the United States and European Union. This means the devices meet established safety and performance criteria for electrosurgical units, allowing them to be legally used in clinical settings within these regions. Always ensure your facility adheres to local regulatory guidelines for proper implementation.

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: LED SpA SURTRON Catalogue | PDF | Clinical Medicine | Surgery, LED SpA Surtron flash 160HF | Radiosurgical unit for monopoly and ..., Surtron 80 D, Surtron 160, Surtron 200, Surtron Flash 160 HF, Surtron ...

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDR

United States Active

FDA_510K

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Manufacturer

Manufacturer
Led Spa

Sources (2)

  • FDA 510(k) K220138 24 fields · synced Sep 18, 2026
  • EUDAMED 1 fields · synced May 18, 2026