510(k) · Cleared
Recalled · 2011Luxtec MLX Light Source
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Integra Luxtec, Inc. · FCW Light Source, Fiberoptic, Routine
Cleared on Jun 18, 2008 after a 22-day review. FDA’s file for it is a 510(k) statement, which names no predicate. It has been recalled 4 times.
- Decided
- Jun 18, 2008
- Review
- 22 days
- Class
- Class II
- Product code
- FCW
- Recalls
- 4
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FCW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 14, 2011 | Not classified | Z-0357-2012 | Process control | A loose screw may result in shifting of components and improper function of the turret or actuator assembly. |
| Oct 14, 2011 | Not classified | Z-0358-2012 | Process control | A loose screw may result in shifting of components and improper function of the turret or actuator assembly. |
| Oct 14, 2011 | Not classified | Z-0356-2012 | Process control | A loose screw may result in shifting of components and improper function of the turret or actuator assembly. |
| Mar 7, 2011 | Not classified | Z-2060-2011 | Process change control | Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down. |
No ancestor or descendant has a Class I recall.
How does its category compare?
All FCW devicesFCW Light Source, Fiberoptic, Routine: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · FCW
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · FCW
Too few FCW 510(k)s in any year since 2007 to give a median.
Recalls per year · FCW
4in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FCW
140in 2025
MAUDE reports naming product code FCW, 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 | 2 | — | 0 | 2 |
| 2009 | 1 | — | 0 | 148 |
| 2010 | 1 | — | 0 | 713 |
| 2011 | 0 | — | 4 | 603 |
| 2012 | 2 | — | 0 | 77 |
| 2013 | 1 | — | 0 | 29 |
| 2014 | 1 | — | 0 | 11 |
| 2015 | 0 | — | 0 | 24 |
| 2016 | 0 | — | 0 | 29 |
| 2017 | 0 | — | 0 | 59 |
| 2018 | 0 | — | 0 | 76 |
| 2019 | 0 | — | 0 | 118 |
| 2020 | 0 | — | 0 | 152 |
| 2021 | 0 | — | 0 | 147 |
| 2022 | 0 | — | 0 | 166 |
| 2023 | 0 | — | 0 | 179 |
| 2024 | 0 | — | 0 | 179 |
| 2025 | 0 | — | 0 | 140 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Integra LUxtec MLX Light Source is designed to supply high intensity
white light through a fiber optic cable for illumination of a surgical field
during a surgical and/or medical procedure.
The Integra Luxtec MLX Light Source should, never be used in ocular
surgery or in a surgical procedure requiring direct illumination of the eye.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K081477 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081477: Luxtec MLX Light Source.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081477
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026