21 C.F.R. § 886.4300

Current through October 31, 2024
Section 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 .

21 C.F.R. §886.4300

52 FR 33355, Sept. 2, 1987, as amended at 65 FR 2321 , 2000