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Code of Federal Regulations Title 21. Food and Drugs § 21.886.1250 Euthyscope

Current as of January 02, 2025 | Updated by Findlaw Staff

(a) Identification. A euthyscope is a device that is a modified AC-powered or battery-powered ophthalmoscope (a perforated mirror device intended to inspect the interior of the eye) that projects a bright light encompassing an arc of about 30 degrees onto the fundus of the eye. The center of the light bundle is blocked by a black disk covering the fovea (the central depression of the macular retinae where only cones are present and blood vessels are lacking). The device is intended for use in the treatment of amblyopia (dimness of vision without apparent disease of the eye).

(b) Classification.

(1) Class I (general controls) for the battery-powered device. The battery-powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

(2) Class II (special controls) for the AC–powered device. The AC–powered device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.

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Cite this article: FindLaw.com - Code of Federal Regulations Title 21. Food and Drugs § 21.886.1250 Euthyscope - last updated January 02, 2025 | https://codes.findlaw.com/cfr/title-21-food-and-drugs/cfr-sect-21-886-1250/

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