510(k) · Cleared
Recalled · Class II · 2014Stellaris PC Vision Enhancement System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bausch & Lomb · HQC Unit, Phacofragmentation
Cleared on Mar 12, 2014 as substantially equivalent to K101325 (Bausch & Lomb, Inc., 2010) and 2 other predicates after a 119-day review. Its family tree reaches back 6 generations to 1985. 7 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 12, 2014
- Review
- 119 days
- Class
- Class II
- Product code
- HQC
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 6 generations to K844373 (1985). 20 ancestors in all. 7 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 5 generations backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- 4 generations backK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- 3 generations backK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
- 2 generations backK082473 Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · Recalled
- 1 generation backK101325 Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 2010 · Recalled
- This deviceK133486 Stellaris PC Vision Enhancement SystemBausch & Lomb · 2014
- Descendant · cites it directly · 2 of its ownK190875 EVA, anterior machine, EVA, combined machine, EVA combined machine…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · Recalled
- Descendant · 2 generations on · 1 of its ownK213467 EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · Recalled
- Descendant · cites it directly · 1 of its ownK170052 Stellaris Elite vision enhancement systemBausch+Lomb · 2017
- Descendant · cites it directly · 1 of its ownK162342 Stellaris Elite Vision Enhancement SystemBausch+Lomb · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK261264 Stellaris Elite™ vision enhancement system; Posterior and Combined…Bausch and Lomb · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K190875EVA, anterior machine, EVA, combined machine, EVA combined machine with laser (DORC…D.O.R.C. Dutch Ophthalmic Research Center (International) · 2019 · cites it directly2descendants
- K213467EVA NEXUS Ophthalmic Surgical SystemD.O.R.C. Dutch Ophthalmic Research Center (International) · 2022 · 2 generations on1descendant
- K170052Stellaris Elite vision enhancement systemBausch+Lomb · 2017 · cites it directly1descendant
- K162342Stellaris Elite Vision Enhancement SystemBausch+Lomb · 2017 · cites it directly1descendant
- K261264Stellaris Elite™ vision enhancement system; Posterior and Combined Procedure Pack (s)…Bausch and Lomb · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −5 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| −4 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| −3 | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | 12 |
| −2 | K082473 | Bausch & Lomb Stellaris Microsurgical System | Bausch & Lomb, Inc. | 2009 | 4 |
| −1 | K101325 | Stellaris PC Vision Enhancement System | Bausch & Lomb, Inc. | 2010 | 1 |
| 0 (this device) | K133486 | Stellaris PC Vision Enhancement System | Bausch & Lomb | 2014 | — |
| +1 | K190875 | EVA, anterior machine, EVA, combined machine, EVA combined machine with laser… | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2019 | 1 |
| +2 | K213467 | EVA NEXUS Ophthalmic Surgical System | D.O.R.C. Dutch Ophthalmic Research Center (International) | 2022 | 6 |
| +1 | K170052 | Stellaris Elite vision enhancement system | Bausch+Lomb | 2017 | — |
| +1 | K162342 | Stellaris Elite Vision Enhancement System | Bausch+Lomb | 2017 | 13 |
| +2 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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? (3)
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 |
|---|---|---|---|
| * | K101325 | Stellaris PC Vision Enhancement SystemSummary page 1…eo-retinal surgery CFR References: 21 CFR 886.4670,21 CFR 886.4150, 21 CFR 886.4390 Product Codes: HQC, HQE, HQF 3. Predicate Devices " K101325 - StellarisePC Vision Enhancement System, Bausch & Lomb " K022760 -Millenium Microsurgical System, Bausch &Lomb "… | 2010 |
| * | K022760 | Millennium Microsurgical SystemSummary page 1…150, 21 CFR 886.4390 Product Codes: HQC, HQE, HQF 3. Predicate Devices " K101325 - StellarisePC Vision Enhancement System, Bausch & Lomb " K022760 -Millenium Microsurgical System, Bausch &Lomb " K071687 -Family of iRiDEX lQ Laser Systems (1Q532, 1Q577,LIQ 630-670, 1Q8… | 2002 |
| * | K071687 | Famili of Iridex IQ Laser SystemsSummary page 1…. Predicate Devices " K101325 - StellarisePC Vision Enhancement System, Bausch & Lomb " K022760 -Millenium Microsurgical System, Bausch &Lomb " K071687 -Family of iRiDEX lQ Laser Systems (1Q532, 1Q577,LIQ 630-670, 1Q8 10) & Delivery Device Accessories 4. Product Descript… | 2008 |
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 4, 2014 | Class II | Z-0863-2015 | Software Manufacturing/Software Deployment | A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. |
| Nov 4, 2014 | Class II | Z-0864-2015 | Software Manufacturing/Software Deployment | A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. |
| Nov 4, 2014 | Class II | Z-0862-2015 | Software Manufacturing/Software Deployment | A software anomaly was identified where the system may automatically transition from "Standby" to "Ready to Fire" state while in surgical use. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 10 of the 20 ancestors have a recall of any class.
- Of its descendants, K190875 (D.O.R.C. Dutch Ophthalmic Research Center (International), 2019) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K101325.
How does its category compare?
All HQC devicesHQC Unit, Phacofragmentation: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 StellarisPC 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 binianual irrigation/aspiration, bipolar coagulation, vitrectomny, viscous fluid injection/removal and air/fluid exchange operations. The laser modes are intended for retinal photocoagulation and laser trabeculaplasty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K133486 · printed Nov 5, 2026
Cite this page
510(k) Report. “K133486: Stellaris PC Vision Enhancement System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K133486
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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