ADATOMED SILICONE OIL OP5000
Device Facts
| Record ID | P910071 |
|---|---|
| Device Name | ADATOMED SILICONE OIL OP5000 |
| Applicant | Bausch & Lomb |
| Product Code | LWL · Ophthalmic |
| Decision Date | Nov 4, 1994 |
| Decision | APPR |
| Regulation | 21 CFR 886.4275 |
| Device Class | Class 3 |
| Attributes | Expedited Review |
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.
