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.

Code of Federal Regulations

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

CFR

886.4300—Intraocular lens guide.

Code of Federal Regulations