21 CFR 886.5925 — Lenses, Soft Contact, Daily Wear
Ophthalmic (OP) · Part 886 Subpart F—Therapeutic Devices · § 886.5925
Identification
A soft (hydrophilic) contact lens is a device intended to be worn directly against the cornea and adjacent limbal and scleral areas of the eye to correct vision conditions or act as a therapeutic bandage. The device is made of various polymer materials the main polymer molecules of which absorb or attract a certain volume (percentage) of 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 |
|---|---|---|---|---|
| LPL | Lenses, Soft Contact, Daily Wear | 2 | 490 | 3rd Party |
| LPM | Lenses, Soft Contact, Extended Wear | 3 | 37 | |
| MVN | Lens, Contact, (Disposable) | 2 | 25 | 3rd Party |
| MZD | System, In-Office Tinting, Contact Lenses | 2 | 1 | 3rd Party |
| NCZ | Lens, Contact, For Color Vision Deficiency | 2 | 1 | 3rd Party |
| NIC | Lens, Contact, For Reading Discomfort | 2 | 1 | 3rd Party |
