CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)

• K Number: K000637
• Device Name: CUSTOMCORNEA MEASUREMENT DEVICE (CCMD)
• Manufacturer: ALCON LABORATORIES, INC.
• Date Cleared: 2000-05-19 ( 84 days)
• Product Code: NCF
• Regulation Number: 886.1760

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

§ 886.1760 Ophthalmic refractometer.

(a)
Identification. An ophthalmic refractometer is an automatic AC-powered device that consists of a fixation system, a measurement and recording system, and an alignment system intended to measure the refractive power of the eye by measuring light reflexes from the retina.(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.

Summary

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