DURASOFT(R) 3 FOR EXT WEAR
Device Facts
| Record ID | P830037 |
|---|---|
| Device Name | DURASOFT(R) 3 FOR EXT WEAR |
| Applicant | Alcon Laboratories, Inc. |
| Product Code | LPM · Ophthalmic |
| Decision Date | Apr 24, 1984 |
| Decision | APWD |
| Regulation | 21 CFR 886.5925 |
| Device Class | Class 3 |
Regulatory Classification
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.
