21 CFR 886.4150
§ 886.4150 Vitreous aspiration and cutting instrument.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 886.4150, § 886.4150 Vitreous aspiration and cutting instrument, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90976
- Permanent ID
ys:prov:90976@1- SHA-256
c191b2da7f6e77df00318890127e35e66c986af21174b92d2fa8557f4f1fc09d
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Full text
(a) Identification. A vitreous aspiration and cutting instrument is an electrically powered device, which may use ultrasound, intended to remove vitreous matter from the vitreous cavity or remove a crystalline lens.
(b) Classification. Class II (special controls). The device, when it is phacofragmentation unit replacement tubing, 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.