21 C.F.R. § 886.4150

Current through October 31, 2024
Section 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 .

21 C.F.R. §886.4150

52 FR 33355, Sept. 2, 1987, as amended at 84 FR 71817 , Dec. 30, 2019