Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart F - Therapeutic Devices / § 886.5838 Nasolacrimal compression device.
§ 886.5838 Nasolacrimal compression device.
(a) Identification. A nasolacrimal compression device is a prescription device that is fitted to apply mechanical pressure to the nasal aspect of the orbital rim to reduce outflow through the nasolacrimal ducts.
(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.