§ 886.4150. Vitreous aspiration and cutting instrument.
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/us/cfr/t21/s§ 886.4150·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(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]