LWL · Fluid, Intraocular
Ophthalmic · 21 CFR 886.4275 · Class 3
Overview
| Product Code | LWL |
|---|---|
| Device Name | Fluid, Intraocular |
| Regulation | 21 CFR 886.4275 |
| Device Class | Class 3 |
| Review Panel | Ophthalmic |
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.
Classification Rationale
Class III.
Cleared Devices (5)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| P910068 | VITREON(R) | Air Products & Chemicals, Inc. | Sep 30, 1997 | APWD |
| P950008 | SILIKON 1000 | Alcon | Sep 25, 1997 | APPR |
| P950018 | PERFLUORON (PURIFIED PERFLUORO-N-OCTANE LIQUID) | Alcon Laboratories | Feb 29, 1996 | APPR |
| P910071 | ADATOMED SILICONE OIL OP5000 | Bausch & Lomb | Nov 4, 1994 | APPR |
| K844895 | OMS SILICONE OIL INJECTOR | Optical Micro Systems, Inc. | Jun 24, 1985 | SESE |
Top Applicants
- Optical Micro Systems, Inc. — 1 clearance
- Bausch & Lomb — 1 clearance
- Alcon Laboratories — 1 clearance
- Alcon — 1 clearance
- Air Products & Chemicals, Inc. — 1 clearance
