UNITED SONICS PHACO MODULE, DF-35
Device Facts
| Record ID | K851210 |
|---|---|
| Device Name | UNITED SONICS PHACO MODULE, DF-35 |
| Applicant | United Sonics, Inc. |
| Product Code | HQC · Ophthalmic |
| Decision Date | May 31, 1985 |
| 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.
