Stellaris Elite vision enhancement system +7 more— 510(k) K261264
Substantially EquivalentBausch and Lomb
FDA 510(k) clearance K261264 for Stellaris Elite vision enhancement system +7 more, Substantially Equivalent on 2026-05-15. Applicant: Bausch and Lomb. Device class: 2.
Clearance details
- Device name as filed
- Stellaris Elite vision enhancement system; Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite Pack (SE5423); 23 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5423B); 25 ga. Posterior Elite Pack (SE5425); 25 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5425B); 27 ga. Bi-Blade Vitreous Cutter Posterior Stellaris Elite Pack (SE5427B); 23 ga. Bi-Blade+ Vitreous Cutter Posterior Stellaris Elite Pack (SE5423BB+); 25 ga. Bi-Blade+
- Applicant
- Bausch and Lomb
- Product code
- Code HQC
- Device class
- Class 2
- Regulation
- 21 CFR 886.4670
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Saint Louis, MO, US
Recent devices under product code HQC
view all- K252052 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
- K250501 — System Sophi
- K243395 — MICOR 700 with Auto I/A
- K242801 — MICOR 700 System (N/A); MICOR 700 drive (FG-50631); MICOR 700 extractor (FG-50621); MICOR 700 vitrector (FG-51185)
- K240169 — Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
More clearances from Bausch and Lomb
view allAdverse events under product code HQC
product code HQC- Injury
- 2,378
- Malfunction
- 8,768
- Total
- 11,146
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.