PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE
Device Facts
| Record ID | K912902 |
|---|---|
| Device Name | PHACOEMULSIFICATION SYSTEM FOR OPHTHALMIC USE |
| Applicant | Site Microsurgical Systems, Inc. |
| Product Code | HQC · Ophthalmic |
| Decision Date | Dec 17, 1991 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 886.4670 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.
