DISPOSABLE MICROKERATOME BLADES-PE

• K Number: K001176
• Device Name: DISPOSABLE MICROKERATOME BLADES-PE
• Manufacturer: OASIS MEDICAL, INC.
• Date Cleared: 2000-09-21 ( 163 days)
• Product Code: HNO
• Regulation Number: 886.4370
• Type: Traditional
• Panel: Ophthalmic
• Reference & Predicate Devices: N/A
• Predicate For: N/A

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

§ 886.4370 Keratome.

(a)
Identification. A keratome is an AC-powered or battery-powered device intended to shave tissue from sections of the cornea for a lamellar (partial thickness) transplant.(b)
Classification. Class I.