510(k) · Cleared
ClearedStellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch and Lomb, Incorporated · HQC Unit, Phacofragmentation
Cleared on Mar 25, 2026 as substantially equivalent to K240169 (Bausch and Lomb, Incorporated, 2024) and 1 other predicate after a 267-day review. Its family tree reaches back 5 generations to 1994.
- Decided
- Mar 25, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K932669 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK932669 Supra-Vit (TM)Medical Instrument Development Laboratories, Inc. · 1994
- 4 generations backK992943 Vit EnhancerMedical Instrument Development Laboratories, Inc. · 1999
- 3 generations backK020911 Mid Labs Autonomous Vit Enhancer (Ave)Medical Instrument Development Laboratories, Inc. · 2002
- 2 generations backK102222 Ultimate Vit Enhamcer (Uve)Medical Instrument Development Laboratories, Inc. · 2011
- 1 generation backK153168 Bi-Blade Vitrectomy CutterMedical Instrument Development Laboratories · 2016
- This deviceK252052 Stellaris Elite™ vision enhancement system (BL11145, BL14455…Bausch and Lomb, Incorporated · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K932669 | Supra-Vit (TM) | Medical Instrument Development Laboratories, Inc. | 1994 | — |
| −4 | K992943 | Vit Enhancer | Medical Instrument Development Laboratories, Inc. | 1999 | — |
| −3 | K020911 | Mid Labs Autonomous Vit Enhancer (Ave) | Medical Instrument Development Laboratories, Inc. | 2002 | — |
| −2 | K102222 | Ultimate Vit Enhamcer (Uve) | Medical Instrument Development Laboratories, Inc. | 2011 | — |
| −1 | K153168 | Bi-Blade Vitrectomy Cutter | Medical Instrument Development Laboratories | 2016 | — |
| 0 (this device) | K252052 | Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455… | Bausch and Lomb, Incorporated | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 K261264 Stellaris Elite™ vision enhancement system…score 13.4 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 |
|---|---|---|---|
| * | K240169 | Stellaris Elite vision enhancement system (BL11145, BL14455, BL15455)Summary page 5…-retinal surgery CFR References: 21 CFR 886.4670, 21 CFR 886.4150, 21 CFR 886.4390 Product Codes: HQC, HQE, HQF 3 Predicate Devices K240169 – Stellaris Elite™ vision enhancement system, Bausch + Lomb K153168 – Bi-Blade Vitrectomy Cutter, Medical Instrument Development… | 2024 |
| * | K153168 | Bi-Blade Vitrectomy CutterSummary page 5…21 CFR 886.4150, 21 CFR 886.4390 Product Codes: HQC, HQE, HQF 3 Predicate Devices K240169 – Stellaris Elite™ vision enhancement system, Bausch + Lomb K153168 – Bi-Blade Vitrectomy Cutter, Medical Instrument Development Laboratories, Inc (MidLabs) 4 Product Description The Bausch + Lomb… | 2016 |
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 32 years and passes through 3 companies; a new generation was cleared every 5.5 years on median.
- None of the 6 ancestors has a recall.
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 Bausch + Lomb Stellaris Elite™ vision enhancement system configured with the laser module is additionally intended for retinal photocoagulation and laser trabeculoplasty.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252052 · printed Nov 4, 2026
Cite this page
510(k) Report. “K252052: Stellaris Elite™ vision enhancement system (BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K252052
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026