KPE 230 AM
Device Facts
| Record ID | K914172 |
|---|---|
| Device Name | KPE 230 AM |
| Applicant | Ipax, Inc. |
| Product Code | HQC · Ophthalmic |
| Decision Date | Oct 25, 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.
