AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE
Device Facts
| Record ID | K941603 |
|---|---|
| Device Name | AMO PHACOFLEX INSERTER DISPOSABLE CARTRIDGE, AND HANDPIECE |
| Applicant | Allergan Medical Optics |
| Product Code | KYB · Ophthalmic |
| Decision Date | Jul 6, 1994 |
| 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.
