Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart B - Diagnostic Devices / § 886.1425 Lens measuring instrument.
§ 886.1425 Lens measuring instrument.
(a) Identification. A lens measuring instrument is an AC-powered device intended to measure the power of lenses, prisms, and their centers (e.g., lensometer).
(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.