Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
Device Facts
| Record ID | K240169 |
|---|---|
| Device Name | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) |
| Applicant | Bausch and Lomb, Incorporated |
| Product Code | HQC · Ophthalmic |
| Decision Date | Jul 26, 2024 |
| 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.
