FLUOROPERM 151-OK, PARAGON HDS 100-OK
Device Facts
| Record ID | K010109 |
|---|---|
| Device Name | FLUOROPERM 151-OK, PARAGON HDS 100-OK |
| Applicant | Paragon Vision Sciences |
| Product Code | MUW · Ophthalmic |
| Decision Date | Feb 28, 2001 |
| Decision | SESU |
| 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.
