CUSTOMEYES(TM) 45L&55L (BUFILCON A)
Device Facts
| Record ID | P850057 |
|---|---|
| Device Name | CUSTOMEYES(TM) 45L&55L (BUFILCON A) |
| Applicant | Ciba Vision Corporation |
| Product Code | LPL · Ophthalmic |
| Decision Date | Apr 14, 1986 |
| Decision | APWD |
| 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.
