510(k) · Cleared
ClearedLafaci
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Vision Pro, LLC · FYD Apparatus, Exhaust, Surgical
Cleared on May 7, 2004 as substantially equivalent to K924732 (Buffalo Filter Co., Inc., 1993) and 5 other predicates after a 277-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- May 7, 2004
- Review
- 277 days
- Class
- Class II
- Product code
- FYD
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 1 generation to K852649 (1985). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK852649 Pressure Regulator/Y ConnectorC.R. Bard, Inc. · 1985
- This deviceK032400 LafaciVision Pro, LLC · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K852649 | Pressure Regulator/Y Connector | C.R. Bard, Inc. | 1985 | — |
| 0 (this device) | K032400 | Lafaci | Vision Pro, LLC | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1996 | 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 FYD? 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 FYD device
- #1 K240127 PlumeSafe X5 Smoke Management Systemscore 8.7 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (14)
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 |
|---|---|---|---|
| * | K924732 | Porta Plumesafe (TM) 601 Smoke Evacuation SystemSummary page 2…Page 1 of 1 Predicate Device(s) 510(k) Device Manufacturer Number K924732 or Dell PlumeSafe and Plume Aspiration fixation Buffalo Filter / Asico K924731 Ring Handpiece (PlumeSafe 601 or 1201)… | 1993 |
| * | K924731 | Plumesafe (TM) 1201 Smoke Evacuation SystemSummary page 2…0(k) Device Manufacturer Number K924732 or Dell PlumeSafe and Plume Aspiration fixation Buffalo Filter / Asico K924731 Ring Handpiece (PlumeSafe 601 or 1201) Unknown Visx Star 3 Plume Evacuation Visx, Inc. K911808… | 1993 |
| * | K911808 | Gemini Ophthalmic Surgery SystemSummary page 2…spiration fixation Buffalo Filter / Asico K924731 Ring Handpiece (PlumeSafe 601 or 1201) Unknown Visx Star 3 Plume Evacuation Visx, Inc. K911808 Accurus Surgical System Alcon Laboratories K935218 Schuco-Vac Model 178 Aspirator… | 1991 |
| * | K935218 | Schuco-Vac Model 178Summary page 2…afe 601 or 1201) Unknown Visx Star 3 Plume Evacuation Visx, Inc. K911808 Accurus Surgical System Alcon Laboratories K935218 Schuco-Vac Model 178 Aspirator Schuco, Inc. Exempt Slade LASIK Aspiration Lid Speculum ASI… | 1994 |
| * | K963434 | Viscous Fluid SystemSummary page 2…uco, Inc. Exempt Slade LASIK Aspiration Lid Speculum ASICO Exempt Kritzinger-Udegraf LASIK Irrigation Cannula- ASICO 16 guage K963434 Continuous Fluid Air Exchange Escalon Trek Medical K852649 Regulator, pressure, gas cylinder… | 1996 |
| * | K852649 | Pressure Regulator/Y ConnectorSummary page 2…pt Kritzinger-Udegraf LASIK Irrigation Cannula- ASICO 16 guage K963434 Continuous Fluid Air Exchange Escalon Trek Medical K852649 Regulator, pressure, gas cylinder C.R.Bard Exempt Gimble-Chayet LASIK Drain Katina… | 1985 |
| * | — | Visx Star 3 Plume Evacuation Named without a submission number | |
| * | — | Slade LASIK Aspiration Lid Speculum Named without a submission number | |
| * | — | Kritzinger-Udegraf LASIK Irrigation Cannula-16 guage Named without a submission number | |
| * | — | Gimble-Chayet LASIK Drain Named without a submission number | |
| * | — | Melki Lasik Flap Stabilizer Named without a submission number | |
| * | — | Maldonado LASIK Posterior Ablation Platform Named without a submission number | |
| * | — | Kraff Nasal Solid Blade Speculum Named without a submission number | |
| * | — | Whitten LASIK Fixation Ring Named without a submission number |
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?
- 1 of the 6 ancestors has a recall of any class.
- 3 other devices also cite its predicate K924732.
How does its category compare?
All FYD devicesFYD Apparatus, Exhaust, Surgical: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FYD
2in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · FYD
71in 2019
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FYD
3so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FYD
15in 2025
MAUDE reports naming product code FYD, 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 | 3 |
| 2008 | 0 | — | 0 | 4 |
| 2009 | 1 | — | 0 | 5 |
| 2010 | 0 | — | 1 | 39 |
| 2011 | 0 | — | 0 | 150 |
| 2012 | 0 | — | 0 | 120 |
| 2013 | 0 | — | 0 | 142 |
| 2014 | 1 | — | 0 | 71 |
| 2015 | 1 | — | 0 | 21 |
| 2016 | 0 | — | 0 | 2 |
| 2017 | 1 | — | 0 | 3 |
| 2018 | 1 | — | 0 | 5 |
| 2019 | 3 | 71 | 0 | 11 |
| 2020 | 1 | — | 0 | 11 |
| 2021 | 1 | — | 0 | 20 |
| 2022 | 1 | — | 0 | 46 |
| 2023 | 0 | — | 0 | 19 |
| 2024 | 2 | — | 0 | 11 |
| 2025 | 0 | — | 0 | 15 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
The LaFaci Surgical System is intended for use during LASIK procedures. The LaFaci Surgical System consists of a reusable Handpiece, Surgical Cart, and disposable Tubing Accessories. The LaFaci System provides ocular fixation and containment of surgical field, comeal flap placement and flap re-positioning, and is used for ophthalmic plume aspiration, irrigation, fluid aspiration, and the delivery of micro filtered air to the surgical field.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032400 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032400: Lafaci.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032400
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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