BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS
Device Facts
| Record ID | P860022 |
|---|---|
| Device Name | BOSTON EQUALENS (ITAFLUROFOCON A)/EQUALENS II (OPRIFOCON A) RIGID GAS PERMEABLE CONTACT LENS |
| Applicant | Bausch & Lomb |
| Product Code | MWL · Ophthalmic |
| Decision Date | Nov 30, 1987 |
| Decision | APPR |
| 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.
