Corneal radius measuring device.

21 C.F.R. § 886.1450
in effectEffective: 2024-07-01
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(a) Identification. A corneal radius measuring device is an AC-powered device intended to measure corneal size by superimposing the image of the cornea on a scale at the focal length of the lens of a small, hand held, single tube penscope or eye gauge magnifier. (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, only when the device does not include computer software in the unit or topographers.

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