21 CFR § 886.4150 - Vitreous aspiration and cutting instrument.
---
identifier: "/us/cfr/t21/s886.4150"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 886.4150 - Vitreous aspiration and cutting instrument."
title_number: 21
title_name: "Food and Drugs"
section_number: "886.4150"
section_name: "Vitreous aspiration and cutting instrument."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "886"
part_name: "OPHTHALMIC DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360 371."
regulatory_source: "52 FR 33355, Sept. 2, 1987, unless otherwise noted."
cfr_part: "886"
---
# 886.4150 Vitreous aspiration and cutting instrument.
(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.
[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]