21 C.F.R. § 886.4300 Intraocular lens guide.
Title 21 - Food and Drugs
(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]
Title 21: Food and Drugs
PART 886—OPHTHALMIC DEVICES
Subpart E—Surgical Devices
§ 886.4300 Intraocular lens guide.
