# Bausch and Lomb, Incorporated

- Location (FDA's records): St. Louis, MO
- FDA decisions: 7 (2016–2026): 6 510(k) clearances and 1 original PMA approval
- Names in FDA's records: Bausch and Lomb, Incorporated (3); Bausch and Lomb (2); Bausch and Lomb, Inc., (2)
- Product codes: HQC (4), MRC (1), MSS (1), LPM (1)
- 510(k) review time since 2016: median 186 days, against 115 for FDA's reviews in the same codes and years (3 of 5 faster)
- Predicates its devices cite: 8 (1 its own); citations of its devices by later devices: 1 (1 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Bausch & Lomb, Inc.: 5 (https://510kreport.com/company/bausch-lomb)
- Polymer Technology Corp.: 1 (https://510kreport.com/company/polymer-technology)
- Medical Instrument Development Laboratories, Inc.: 1 (https://510kreport.com/company/medical-instrument-development-laboratories)

## Its most-cited devices
- K240169: Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (2024), cited by 1

## Recent decisions
- 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™+ (May 15, 2026)
- K252052: Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E) (Mar 25, 2026)
- K240169: Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455) (Jul 26, 2024)
- K232084: Stellaris Elite vision enhancement system (Feb 26, 2024)
- P170035: Bausch + Lomb Ultra (samfilcon A) Contact Lenses (Apr 30, 2018)
- K180319: Bausch + Lomb Boston Advance Cleaner, Bausch + Lomb Boston Advance Conditioning Solution (Mar 27, 2018)
- K161012: Easy-Load Lens Delivery System (Jul 6, 2016)

Source page: https://510kreport.com/company/bausch-and-lomb