← Product Code [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC) · K261264

# Stellaris 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™+ (K261264)

_Bausch and Lomb · HQC · May 15, 2026 · Ophthalmic · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K261264

## Device Facts

- **Applicant:** Bausch and Lomb
- **Product Code:** [HQC](/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC.md)
- **Decision Date:** May 15, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 886.4670
- **Device Class:** Class 2
- **Review Panel:** Ophthalmic

## Regulatory Identification

A phacofragmentation system is an AC-powered device with a fragmenting needle intended for use in cataract surgery to disrupt a cataract with ultrasound and extract the cataract.

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**Source:** [https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K261264](https://fda.innolitics.com/submissions/OP/subpart-e%E2%80%94surgical-devices/HQC/K261264)

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