Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart B - Diagnostic Devices / § 886.1050 Adaptometer (biophotometer).
§ 886.1050 Adaptometer (biophotometer).
(a) Identification. An adaptometer (biophotometer) is an AC-powered device that provides a stimulating light source which has various controlled intensities intended to measure the time required for retinal adaptation (regeneration of the visual purple) and the minimum light threshold.
(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.