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FDA 510(k)

Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)

K-Number: K252052 · 2026-03-25

ApplicantBausch and Lomb, Incorporated
Decision Date2026-03-25
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) is a medical device manufactured by Bausch and Lomb, Incorporated. It received FDA 510(k) clearance on 2026-03-25 under approval number K252052. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)?

Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) is a medical device that received FDA 510(k) clearance on 2026-03-25. It is manufactured by Bausch and Lomb, Incorporated. The 510(k) number is K252052.

When was Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) approved by the FDA?

Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) received FDA 510(k) clearance on 2026-03-25, under approval number K252052.

What company makes Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)?

Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) is manufactured by Bausch and Lomb, Incorporated.

What is the FDA product code for Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)?

The FDA product code for Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) is HQC.

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Other Devices by Bausch and Lomb, Incorporated

K180319Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution K240169Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)

Related Devices (Code: HQC)

K160236Dual Pump PackAbbott Medical Optics, Inc. K170052Stellaris Elite vision enhancement systemBausch+Lomb K161794CENTURION Vision System (Active SentryTM)Alcon Research, Ltd. K162342Stellaris Elite Vision Enhancement SystemBausch+Lomb K191650LEGION SystemAlcon Research, LLC K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC connector), EVA combined machine with laser (SMA connector)D.O.R.C. Dutch Ophthalmic Research Center (International)

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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