21 CFR 886.1050
§ 886.1050 Adaptometer (biophotometer).
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 886.1050, § 886.1050 Adaptometer (biophotometer), United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90891
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.