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Unit, Phacofragmentation

FDA product code HQC · 309 cleared devices

Class 2 Ophthalmic
Regulation
21 CFR 886.4670
Review panel
OP
Implant
No
Life sustaining
No
Third party review
Yes
GMP exempt
No
Clearance span
1977-09-26 – 2026-05-15
HQC 2026-05-15

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™+

Applicant Bausch and Lomb

K number K261264

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