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Bausch & Lomb

FDA 510(k) & PMA Approved Devices — 8 products

Total Devices8
Categories0
Latest FDA decision
TypeNumberDevice NameCodeDateActions
510(k) 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™+HQC2026-05-15 View
510(k) K232084 Stellaris Elite vision enhancement systemHQC2024-02-26 View
510(k) K132481 EASY-LOAD LENS DELIVERY SYSTEMMSS2013-12-27 View
510(k) K132593 CRYSTALSERT DELIVERY SYSTEMMSS2013-09-17 View
510(k) K123736 CRYSTALSERT DELIVERY SYSTEMMSS2013-05-16 View
510(k) K061157 SOFLENS ONE DAY PLUS DISPOSABLE (HILAFILCON B) VISIBILITY TINTED CONTACT LENSMVN2006-06-22 View
510(k) K040913 NGDI (NEXT GENERATION DIAGNOSTIC INSTRUMENT)MXK2004-07-23 View
510(k) K020927 BAUSCH & LOMB SOFLENS MULTIFOCAL (POLYMACON) VISIBILITY TINTED CONTACT LENSLPL2002-05-16 View
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