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Code · CFR · Title 21 — Food and Drugs · Part 886 — Ophthalmic Devices · § 886.1120

§ 886.1120. Ophthalmic camera.

76 words·~1 min read·/us/cfr/t21/s§ 886.1120·

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(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. [55 FR 48441, Nov. 20, 1990, as amended at 84 FR 71817, Dec. 30, 2019]
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§ 886.1120
Ophthalmic camera.
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