WOLDOFF PRISMATIC BICONCAVE LENS
Device Facts
| Record ID | K894421 |
|---|---|
| Device Name | WOLDOFF PRISMATIC BICONCAVE LENS |
| Applicant | Ocular Instruments, Inc. |
| Product Code | HJK · Ophthalmic |
| Decision Date | Oct 4, 1989 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.1385 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A polymethylmethacrylate (PMMA) diagnostic contact lens is a device that is a curved shell of PMMA intended to be applied for a short period of time directly on the globe or cornea of the eye for diagnosis or therapy of intraocular abnormalities.
