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Electronic Code of Federal Regulations

e-CFR data is current as of March 26, 2020

Title 21Chapter ISubchapter HPart 886Subpart E → §886.4150


Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart E—Surgical Devices


§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]

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