DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT
Device Facts
| Record ID | K954603 |
|---|---|
| Device Name | DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT |
| Applicant | Wesley Jessen Corp. |
| Product Code | LPL · Ophthalmic |
| Decision Date | Jan 4, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.5925 |
| Device Class | Class 2 |
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.
