Title 21: Food and Drugs
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/ PART 886 - OPHTHALMIC DEVICES
/ Subpart E - Surgical Devices / § 886.4300 Intraocular lens guide.
§ 886.4300 Intraocular lens guide.
(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.