WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR

• K Number: K000768
• Device Name: WALLACH QUANTUM 500 ELECTROSURGICAL GENERATOR
• Manufacturer: WALLACH SURGICAL DEVICES, INC.
• Date Cleared: 2000-04-11 ( 33 days)
• Product Code: EKZ
• Regulation Number: 872.4920

Intended Use

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Device Description

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Predicate Devices

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Reference Devices

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AI/ML (Artificial Intelligence / Machine Learning)

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Therapeutic

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Diagnostic

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SaMD (Software as a Medical Device)

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IVD (In Vitro Diagnostic)

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PCCP (Predetermined Change Control Plan) Authorized

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Overview

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Regulation Number and Section

§ 872.4920 Dental electrosurgical unit and accessories.

(a)
Identification. A dental electrosurgical unit and accessories is an AC-powered device consisting of a controlled power source and a set of cutting and coagulating electrodes. This device is intended to cut or remove soft tissue or to control bleeding during surgical procedures in the oral cavity. An electrical current passes through the tip of the electrode into the tissue and, depending upon the operating mode selected, cuts through soft tissue or coagulates the tissue.(b)
Classification. Class II.

Summary

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