DANKER SILICONE LENS (DIMEFOCON-A)
Device Facts
| Record ID | P790010 |
|---|---|
| Device Name | DANKER SILICONE LENS (DIMEFOCON-A) |
| Applicant | Ciba Vision Corporation |
| Product Code | HQD · Ophthalmic |
| Decision Date | May 28, 1982 |
| Decision | APWD |
| Regulation | 21 CFR 886.5916 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A rigid gas permeable contact lens is a device intended to be worn directly against the cornea of the eye to correct vision conditions. The device is made of various materials, such as cellulose acetate butyrate, polyacrylate-silicone, or silicone elastomers, whose main polymer molecules generally do not absorb or attract water.
