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.
Summary
Bausch and Lomb's record starts with the Stellaris Elite vision enhancement system, then lists posterior and combined procedure packs by gauge and model number (23, 25 and 27 ga.). The device name is cut off partway through that list. The product code is HQC, phacofragmentation units.
Class II, 21 CFR 886.4670. Ophthalmic is both the classification panel and the review panel, and it came in as a Special 510(k).
Bausch and Lomb filed from Saint Louis, Missouri. Review took 29 calendar days (April 16 to May 15, 2026).
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
- Product 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- K262097 — MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)
- 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)
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.