Bausch and Lomb, Incorporated · Class II · Cleared Mar 25, 2026
| K-number | K252052 |
| Device name | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) |
| Applicant | Bausch and Lomb, Incorporated |
| Product code | HQC |
| Device class | Class II |
| Decision date | Mar 25, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 886.4670 |
The Stellaris Elite™ vision enhancement system is an integrated ophthalmic surgical system for cataract emulsification, removal, and anterior/posterior segment vitrectomy. It performs phacoemulsification, irrigation/aspiration, vitrectomy, coagulation, fluid/air exchange, and endoillumination; with a laser module option for retinal photocoagulation and laser trabeculoplasty.
The subject device matches the predicate in manufacturer, product codes, intended use, and core functions. Minor differences exist: compressor pressure increased from 42 PSI to 52.5 PSI, and vacuum fluidics upgraded from 7.5K to 12.5K capability. The Bi-Blade+ cutter increased maximum cut rate from 8,000 to 25,000 cpm and expanded gauge sizes from 20G to 23/25/27G.
Compliance demonstrated with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-8, IEC 60601-2-2, IEC 60601-2-22, IEC 80601-2-58, IEC 62366-1, IEC 60825-1, ISO 10993-1, and IEC 62304:2006+A1:2015 for software lifecycle processes.
The subject device has identical intended use and similar technological characteristics to the predicate K240169. The differences in compressor pressure and vacuum fluidics capacity, along with increased cutter speed and gauge options, do not raise new safety or performance concerns and are supported by non-clinical testing, electrical/EMC compliance, biocompatibility, and software validation.
View the full FDA submission: accessdata.fda.gov