OMS SILICONE OIL INJECTOR
Device Facts
| Record ID | K844895 |
|---|---|
| Device Name | OMS SILICONE OIL INJECTOR |
| Applicant | Optical Micro Systems, Inc. |
| Product Code | LWL · Ophthalmic |
| Decision Date | Jun 24, 1985 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4275 |
| Device Class | Class 3 |
Regulatory Classification
Identification
An intraocular fluid is a device consisting of a nongaseous fluid intended to be introduced into the eye to aid performance of surgery, such as to maintain anterior chamber depth, preserve tissue integrity, protect tissue from surgical trauma, or function as a tamponade during retinal reattachment.
