KELMAN(TM) OMNIFIT II MODEL 2100
Device Facts
| Record ID | P850059 |
|---|---|
| Device Name | KELMAN(TM) OMNIFIT II MODEL 2100 |
| Applicant | Bausch & Lomb Surgical, Inc. |
| Product Code | HQL · Ophthalmic |
| Decision Date | Jul 31, 1986 |
| Decision | APWD |
| Regulation | 21 CFR 886.3600 |
| Device Class | Class 3 |
Regulatory Classification
Identification
An intraocular lens is a device made of materials such as glass or plastic intended to be implanted to replace the natural lens of an eye.
