DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS
Device Facts
| Record ID | P850072S002 |
|---|---|
| Device Name | DURASOFT4 (OFILCON A) SPHERICAL HYDROPHILIC LENS |
| Applicant | Ciba Vision Corporation |
| Product Code | LPM · Ophthalmic |
| Decision Date | Feb 24, 1988 |
| Decision | APPR |
| 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.
