NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON

• K Number: K001326
• Device Name: NATURAL-IRIS PRE-PIGMENTED CORNEAL BUTTON
• Manufacturer: OCULAR CONCEPTS LLC.
• Date Cleared: 2000-06-13 ( 48 days)
• Product Code: NCK
• Regulation Number: 886.3200

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

§ 886.3200 Artificial eye.

(a)
Identification. An artificial eye is a device resembling the anterior portion of the eye, usually made of glass or plastic, intended to be inserted in a patient's eye socket anterior to an orbital implant, or the eviscerated eyeball, for cosmetic purposes. The device is not intended to be implanted.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9, if the device is made from the same materials, has the same chemical composition, and uses the same manufacturing processes as currently legally marketed devices.

Summary

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