Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart B - Diagnostic Devices / § 886.1120 Ophthalmic camera.
§ 886.1120 Ophthalmic camera.
(a) Identification. An ophthalmic camera is an AC-powered device intended to take photographs of the eye and the surrounding area.
(b) Classification. Class II (special controls). The device, when it is a photorefractor or a general-use ophthalmic camera, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9.