OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C)
Device Facts
| Record ID | K952260 |
|---|---|
| Device Name | OP-2 (LOTIFOCON B) & OP-6 (LOTIFOCON C) |
| Applicant | Stellar Contact Lens, Inc. |
| Product Code | HQD · Ophthalmic |
| Decision Date | Jan 3, 1996 |
| Decision | SESE |
| Submission Type | Traditional |
| 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.
