AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38
Device Facts
| Record ID | K925254 |
|---|---|
| Device Name | AMO(R) FLRX-TIP(TM) DISPOS I/A HANDPIECE, OPO-38 |
| Applicant | Allergan Medical Optics |
| Product Code | HQC · Ophthalmic |
| Decision Date | Jan 7, 1993 |
| 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.
