![]() |
Code of Federal Regulations (Last Updated: July 5, 2024) |
![]() |
Title 21 - Food and Drugs |
![]() |
Chapter I - Food and Drug Administration, Department of Health and Human Services |
![]() |
SubChapter H - Medical Devices |
![]() |
Part 886 - Ophthalmic Devices |
![]() |
Subpart E - Surgical Devices |
§ 886.4355 - xxx
Latest version.
-
§ 886.4355 Corneal inlay inserter handle.
(a) Identification. The corneal inlay inserter handle is a hand-held device intended to be used as an accessory to a corneal inlay inserter. The device extends the length of the inlay inserter to aid in delivering the inlay implant.
(b) Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 886.9. CITA>
[84 FR 14870, Apr. 12, 2019]