21 CFR 886.1870
§ 886.1870 Stereoscope.
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 886.1870, § 886.1870 Stereoscope, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90952
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Full text
(a) Identification. A stereoscope is an AC-powered or battery-powered device that combines the images of two similar objects to produce a three-dimensional appearance of solidity and relief. It is intended to measure the angle of strabismus (eye muscle deviation), evaluate binocular vision (usage of both eyes to see), and guide a patient's corrective exercises of eye muscles.
(b) Classification. Class I (general controls). The AC-powered device and the battery-powered device are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The battery-powered 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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.