HOYA IS INJECTOR SYSTEM
Device Facts
| Record ID | K081346 |
|---|---|
| Device Name | HOYA IS INJECTOR SYSTEM |
| Applicant | Hoya Surgical Optics, Inc. |
| Product Code | MSS · Ophthalmic |
| Decision Date | Mar 23, 2009 |
| 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.
