21 CFR 886.5916 — Lens, Contact (Other Material) - Daily
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5916
Identification
A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.
Classification Rationale
(1) Class II if the device is intended for daily wear only.(2) Class III if the device is intended for extended wear.
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HQD | Lens, Contact (Other Material) - Daily | 2 | 120 | 3rd Party |
| MUW | Lens, Contact (Orthokeratology) | 2 | 6 | |
| MWL | Lens, Contact (Rigid Gas Permeable), Extended Wear | 3 | 6 | |
| NUU | Lens, Contact, Orthokeratology, Overnight | 3 | 4 |
