§886.4150. Vitreous aspiration and cutting instrument.
21 C.F.R. § 886.4150
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.
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.
Notes, amendments, and revision history
Amendments
[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]
Authority
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l, 371.
Source
Source: 52 FR 33355, Sept. 2, 1987, unless otherwise noted.
Amendments
[52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817, Dec. 30, 2019]