FLUOROCON TM-60
Device Facts
| Record ID | P890020 |
|---|---|
| Device Name | FLUOROCON TM-60 |
| Applicant | Ciba Vision Corporation |
| Product Code | MWL · Ophthalmic |
| Decision Date | Jun 23, 1989 |
| Decision | APWD |
| Regulation | 21 CFR 886.5916 |
| Device Class | Class 3 |
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.
