510(k) · Cleared
ClearedFaros Surgical System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oertli Instrumente AG · HQC Unit, Phacofragmentation
Cleared on Jun 27, 2024 as substantially equivalent to K133562 (Oertli Instrumente AG, 2014) after a 268-day review. Its family tree reaches back 7 generations to 1985.
- Decided
- Jun 27, 2024
- Review
- 268 days
- Class
- Class II
- Product code
- HQC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K844373 (1985). 21 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK844373 O.M.S. Ultra-PhacoOptical Micro Systems, Inc. · 1985
- 6 generations backK981116 Sovereign Cataract Extraction SystemAllergan, Inc. · 1998 · Recalled
- 5 generations backK021566 InfinitiAlcon Laboratories, Inc. · 2002 · Recalled
- 4 generations backK063331 Bausch & Lomb NGX Microsurgical SystemBausch & Lomb, Inc. · 2006 · Recalled
- 3 generations backK082473 Bausch & Lomb Stellaris Microsurgical SystemBausch & Lomb, Inc. · 2009 · Recalled
- 2 generations backK101325 Stellaris PC Vision Enhancement SystemBausch & Lomb, Inc. · 2010 · Recalled
- 1 generation backK133562 Catarhex 3Oertli Instrumente AG · 2014
- This deviceK233398 Faros Surgical SystemOertli Instrumente AG · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K844373 | O.M.S. Ultra-Phaco | Optical Micro Systems, Inc. | 1985 | — |
| −6 | K981116 | Sovereign Cataract Extraction System | Allergan, Inc. | 1998 | 1 |
| −5 | K021566 | Infiniti | Alcon Laboratories, Inc. | 2002 | 3 |
| −4 | K063331 | Bausch & Lomb NGX Microsurgical System | Bausch & Lomb, Inc. | 2006 | 12 |
| −3 | K082473 | Bausch & Lomb Stellaris Microsurgical System | Bausch & Lomb, Inc. | 2009 | 4 |
| −2 | K101325 | Stellaris PC Vision Enhancement System | Bausch & Lomb, Inc. | 2010 | 1 |
| −1 | K133562 | Catarhex 3 | Oertli Instrumente AG | 2014 | — |
| 0 (this device) | K233398 | Faros Surgical System | Oertli Instrumente AG | 2024 | — |
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 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 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? (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 |
|---|---|---|---|
| * | K133562 | Catarhex 3Summary page 5…HQC Subsequent Product Codes HQE, GEI Predicate Device CataRhex 3 Cataract Surgery System (K133562) Intended Use/Indications for Use: The Faros is a surgery system used by ophthalmologists during cataract surgery. It is design… | 2014 |
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 39 years and passes through 5 companies; a new generation was cleared every 4.1 years on median.
- 11 of the 21 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. 2024, 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 Faros is a surgery system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation and aspiration, as well as ancillary functions such as vitreous cutting along with bipolar diathermy. Faros is used for these surgical interventions in the anterior eye segment: – Irrigation and aspiration (I/Afunction) – Ultrasound phaco (PHACO function) – Biopolar…
Read the full statement (104 words)
The Faros is a surgery system used by ophthalmologists during cataract surgery. It is designed for use in anterior segment procedures that require simultaneous lens fragmentation, irrigation and aspiration, as well as ancillary functions such as vitreous cutting along with bipolar diathermy.
Faros is used for these surgical interventions in the anterior eye segment:
– Irrigation and aspiration (I/Afunction)
– Ultrasound phaco (PHACO function)
– Biopolar diathermy for hemostasis and coaptation of the conjunctiva (DIA function)
– Bipolar diathermic capsulotomy (CAPS function)
– Operation of a vitrectomy instrument (VIT function)
The device may only be used with the instruments recommended and supplied by Oertli.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K233398 · printed Nov 5, 2026
Cite this page
510(k) Report. “K233398: Faros Surgical System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K233398
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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