AUTOMATIC VISUAL FIELD PLOTTER AP-125

• K Number: K961090
• Device Name: AUTOMATIC VISUAL FIELD PLOTTER AP-125
• Manufacturer: KOWA OPTIMED, INC.
• Date Cleared: 1996-06-17 ( 90 days)
• Product Code: HPT
• Regulation Number: 886.1605
• Type: Traditional
• Panel: Ophthalmic
• Age Range: N/A
• 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

§ 886.1605 Perimeter.

(a)
Identification. A perimeter is an AC-powered or manual device intended to determine the extent of the peripheral visual field of a patient. The device projects light on various points of a curved surface, and the patient indicates whether he or she sees the light.(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. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.