Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)— 510(k) K252052
Substantially EquivalentBausch and Lomb, Incorporated
FDA 510(k) clearance K252052 for Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E), Substantially Equivalent on 2026-03-25. Applicant: Bausch and Lomb, Incorporated. Device class: 2.
Summary
Bausch and Lomb's Stellaris Elite vision enhancement system is filed under HQC, phacofragmentation units. The name lists seven designations: BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E and SE15565E.
Class II, 21 CFR 886.4670. It was a Traditional 510(k), and Ophthalmic is both the classification panel and the review panel.
Bausch and Lomb filed from St. Louis, Missouri. The decision came 267 calendar days after FDA received it (July 1, 2025 to March 25, 2026).
Clearance details
- Applicant
- Bausch and Lomb, Incorporated
- 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
- Traditional
- Location
- St. Louis, MO, US
Recent devices under product code HQC
view all- K262097 — MICOR 700 System (N/A); MICOR 700 Extractor (FG-50621)
- K261264 — Stellaris Elite vision enhancement system +7 more
- 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, Incorporated
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.