D.O.R.C. MICRODIATHERMY SYSTEM

• K Number: K962135
• Device Name: D.O.R.C. MICRODIATHERMY SYSTEM
• Manufacturer: DUTCH OPHTHALMIC USA, INC.
• Date Cleared: 1996-08-29 ( 87 days)
• Product Code: HQO
• Regulation Number: 886.4115
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: N/A
• Predicate For: K990064

Intended Use

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Device Description

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AI/ML Overview

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Summary

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Regulation Number and Section

§ 886.4115 Thermal cautery unit.

(a)
Identification. A thermal cautery unit is an AC-powered or battery-powered device intended for use during ocular surgery to coagulate tissue or arrest bleeding by heat conducted through a wire tip.(b)
Classification. Class II.