Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart E - Surgical Devices / § 886.4150 Vitreous aspiration and cutting instrument.
§ 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.