§ 886.4300. Intraocular lens guide.
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/us/cfr/t21/s§ 886.4300·A research copy — for the controlling text, always check the official state or federal source. Not legal advice.
(a)Identification. An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.
(b)Classification. Class I (general controls). Except when used as folders or injectors for soft or foldable intraocular lenses, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 886.9. [52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321, 2000]