510(k) · Cleared
ClearedStellaris 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™+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch and Lomb · HQC Unit, Phacofragmentation
Cleared on May 15, 2026 as substantially equivalent to K162342 (Bausch+Lomb, 2017) after a 29-day review. Its family tree reaches back 8 generations to 1985.
- Decided
- May 15, 2026
- Review
- 29 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to K844373 (1985). 23 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 7 generations backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- 6 generations backK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- 5 generations backK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
- 4 generations backK082473 Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · Recalled
- 3 generations backK101325 Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 2010 · Recalled
- 2 generations backK133242 Stellaris Vision Enhancement SystemBausch & Lomb · 2014
- 1 generation backK162342 Stellaris Elite Vision Enhancement SystemBausch+Lomb · 2017 · Recalled
- This deviceK261264 Stellaris Elite™ vision enhancement system; Posterior and Combined…Bausch and Lomb · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −7 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| −6 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| −5 | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | 12 |
| −4 | K082473 | Bausch & Lomb Stellaris Microsurgical System | Bausch & Lomb, Inc. | 2009 | 4 |
| −3 | K101325 | Stellaris PC Vision Enhancement System | Bausch & Lomb, Inc. | 2010 | 1 |
| −2 | K133242 | Stellaris Vision Enhancement System | Bausch & Lomb | 2014 | — |
| −1 | K162342 | Stellaris Elite Vision Enhancement System | Bausch+Lomb | 2017 | 13 |
| 0 (this device) | K261264 | Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure… | Bausch and Lomb | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in HQC? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new HQC device
- #1 K250501 System Sophiscore 13.0 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K162342 | Stellaris Elite Vision Enhancement SystemSummary page 7…886.4150 - Vitreous Aspiration and Cutting Instrument (HQE) 21 CFR Part 876.1500 - Endoscope and Accessories (MPA) 3 Predicate Devices K162342 – Stellaris Elite™ vision enhancement system, Bausch + Lomb 4 Reference Devices K252052 – Stellaris Elite™ vision enhancement s… | 2017 |
| † | K252052 | Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565… | 2026 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 41 years and passes through 7 companies; a new generation was cleared every 4.1 years on median.
- 12 of the 23 ancestors have a recall of any class.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · HQC
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HQC
267in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HQC
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · HQC
1,799in 2025
MAUDE reports naming product code HQC, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 341 |
| 2008 | 4 | 162 | 1 | 444 |
| 2009 | 5 | 131 | 1 | 540 |
| 2010 | 3 | 142 | 22 | 2,431 |
| 2011 | 5 | 129 | 4 | 1,802 |
| 2012 | 5 | 125 | 1 | 2,277 |
| 2013 | 0 | — | 0 | 2,772 |
| 2014 | 4 | 135 | 1 | 2,740 |
| 2015 | 3 | 124 | 0 | 3,355 |
| 2016 | 1 | — | 0 | 3,374 |
| 2017 | 3 | 214 | 0 | 2,781 |
| 2018 | 0 | — | 2 | 2,416 |
| 2019 | 4 | 126 | 0 | 2,287 |
| 2020 | 4 | 227 | 0 | 1,217 |
| 2021 | 1 | — | 0 | 1,673 |
| 2022 | 4 | 245 | 5 | 1,907 |
| 2023 | 1 | — | 1 | 1,799 |
| 2024 | 5 | 197 | 0 | 2,120 |
| 2025 | 3 | 267 | 1 | 1,799 |
| 2026 | 3 | 115 | 0 | — |
What is it indicated for?
The Bausch + Lomb Stellaris Elite™ Vision Enhancement System is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Stellaris…
Read the full statement (228 words)
The Bausch + Lomb Stellaris Elite™ Vision Enhancement System is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Stellaris Elite™ Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.
The Bausch + Lomb posterior and combined procedure packs are intended for use with the Bausch + Lomb Stellaris Vision Enhancement Systems which are intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. They provide capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, vitrectomy, and air/fluid exchange operations.
The Bausch + Lomb Stellaris Elite™ Vision Enhancement System is intended for the emulsification and removal of cataracts, anterior and posterior segment vitrectomy. The system is designed for use in both anterior and posterior segment surgeries. It provides capabilities for phacoemulsification, coaxial and bimanual irrigation/aspiration, bipolar coagulation, vitrectomy, viscous fluid injection/removal and air/fluid exchange operations. The Stellaris Elite™ Vision Enhancement System configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.
The Bausch + Lomb Light Pipes are intended for use with the Bausch + Lomb Stellaris Vision Enhancement Systems for use during anterior and posterior segment surgeries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K261264 · printed Nov 6, 2026
Cite this page
510(k) Report. “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™+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K261264
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026