21 CFR 886.5838
§ 886.5838 Nasolacrimal compression device.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.5838, § 886.5838 Nasolacrimal compression device, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/91021
- Permanent ID
ys:prov:91021@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.