GV3000 PHACOEMULSIFIER/FRAGMENTER
Device Facts
| Record ID | K883097 |
|---|---|
| Device Name | GV3000 PHACOEMULSIFIER/FRAGMENTER |
| Applicant | D.O.R.C. Intl. B.V. |
| Product Code | HQC · Ophthalmic |
| Decision Date | Dec 6, 1988 |
| 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.
