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Stellaris Elite™ vision enhancement system +7 more models

FDA 510(k)

Class II (US FDA 510(k))

510(k) K261264

by Bausch and Lomb

Identifiers

510(k) Number
K261264 FDA 510(k)
FDA Product Code
HQC FDA 510(k)
Models / Variants
Stellaris Elite™ vision enhancement system FDA 510(k)
Posterior and Combined Procedure Pack(s): 23 ga. Posterior Elite™ Pack (SE5423) FDA 510(k)
23 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423B) FDA 510(k)
25 ga. Posterior Elite™ Pack (SE5425) FDA 510(k)
25 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5425B) FDA 510(k)
27 ga. Bi-Blade™ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5427B) FDA 510(k)
23 ga. Bi-Blade™+ Vitreous Cutter Posterior Stellaris Elite™ Pack (SE5423BB+) FDA 510(k)
25 ga. Bi-Blade™+ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 886.4670 FDA 510(k)
Regulation Number
886.4670 FDA 510(k)
Advisory Committee
Ophthalmic FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

Stellaris Elite™ vision enhancement system +7 more models by Bausch and Lomb — Class II — FDA_510K — listed in FDA 510(k) — 8 models

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Bausch and Lomb

Sources (1)

  • FDA 510(k) K261264 24 fields · synced Jun 18, 2026