A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5
Device Facts
| Record ID | K002986 |
|---|---|
| Device Name | A.R.C. LOW BUBBLE TURBO NEEDLE, MODEL WE0106.5 |
| Applicant | A.R.C. Laser AG |
| Product Code | HQC · Ophthalmic |
| Decision Date | Nov 29, 2000 |
| 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.
