PASSPORT FOLDABLE LENS PLACEMENT SYSTEM
Device Facts
| Record ID | K951292 |
|---|---|
| Device Name | PASSPORT FOLDABLE LENS PLACEMENT SYSTEM |
| Applicant | Chiron Vision Corp. |
| Product Code | KYB · Ophthalmic |
| Decision Date | Jun 2, 1995 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4300 |
| Device Class | Class 1 |
Regulatory Classification
Identification
An intraocular lens guide is a device intended to be inserted into the eye during surgery to direct the insertion of an intraocular lens and be removed after insertion is completed.