OPTIMED GLAUCOMA PRESSURE REGULATOR
Device Facts
| Record ID | K903462 |
|---|---|
| Device Name | OPTIMED GLAUCOMA PRESSURE REGULATOR |
| Applicant | Optimed, Inc. |
| Product Code | KYF · Ophthalmic |
| Decision Date | Oct 16, 1990 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.3920 |
| Device Class | Class 2 |
Regulatory Classification
Identification
An aqueous shunt is an implantable device intended to reduce intraocular pressure in the anterior chamber of the eye in patients with neovascular glaucoma or with glaucoma when medical and conventional surgical treatments have failed.
Special Controls
*Classification.* Class II. The special controls for this device are FDA's:(1) “Use of International Standard ISO 10993 ‘Biological Evaluation of Medical Devices—Part I: Evaluation and Testing,’ ” (2) “510(k) Sterility Review Guidance of 2/12/90 (K90-1),” and (3) “Aqueous Shunts—510(k) Submissions.”
