PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)
Device Facts
| Record ID | K010126 |
|---|---|
| Device Name | PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED) |
| Applicant | Cl-Tinters |
| Product Code | LPL · Ophthalmic |
| Decision Date | Mar 12, 2001 |
| 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.
