Cleared Special

Stellaris Elite™ vision enhancement system (K261264) - FDA 510(k) Clearance

Also marketed or referenced as:
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™+

Class II Ophthalmic device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K261264 · Bausch and Lomb · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
29d
Days
Class 2
Risk

K261264 is an FDA 510(k) clearance for the Stellaris Elite™ vision enhancement system. Classified as Unit, Phacofragmentation (product code HQC), Class II - Special Controls.

Submitted by Bausch and Lomb (Saint Louis, US). The FDA issued a Cleared decision on May 15, 2026 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.4670 - the FDA ophthalmic device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Bausch and Lomb devices

Submission Details

510(k) Number K261264 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 2026
Decision Date May 15, 2026
Days to Decision 29 days
Submission Type Special
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
81d faster than avg
Panel avg: 110d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code HQC Unit, Phacofragmentation
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.4670
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - HQC Unit, Phacofragmentation

All 315
Devices cleared under the same product code (HQC) and FDA review panel - the closest regulatory comparables to K261264.
Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
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Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)
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