ROSE K LENS
Device Facts
| Record ID | K945955 |
|---|---|
| Device Name | ROSE K LENS |
| Applicant | Rose K International , Ltd. |
| Product Code | HQD · Ophthalmic |
| Decision Date | Feb 7, 1995 |
| 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.
