FDA 510(k)

Stellaris Elite vision enhancement system

K-Number: K232084 · 2024-02-26

Decision Date2024-02-26

Product CodeHQC

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

Stellaris Elite vision enhancement system is a medical device manufactured by Bausch and Lomb. It received FDA 510(k) clearance on 2024-02-26 under approval number K232084. 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?

Stellaris Elite vision enhancement system is a medical device that received FDA 510(k) clearance on 2024-02-26. It is manufactured by Bausch and Lomb. The 510(k) number is K232084.

When was Stellaris Elite vision enhancement system approved by the FDA?

Stellaris Elite vision enhancement system received FDA 510(k) clearance on 2024-02-26, under approval number K232084.

What company makes Stellaris Elite vision enhancement system?

Stellaris Elite vision enhancement system is manufactured by Bausch and Lomb.

What is the FDA product code for Stellaris Elite vision enhancement system?

The FDA product code for Stellaris Elite vision enhancement system is HQC.

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Other Devices by Bausch and Lomb

K261264Stellaris 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+

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

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