510(k) K081477 ยท FCW Light Source, Fiberoptic, Routine
LUXTEC MLX LIGHT SOURCE
| Applicant | Integra Luxtec, Inc., West Boylston MA, US |
| Decision | Substantially Equivalent, Jun 18, 2008 |
| Received | May 27, 2008 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K081477
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 2, 2011 | Integra LifeSciences Corp. Integra Surgical Luxtec MLX Light Source
Catalog Numbers: 00MLX
Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable for Terminated |
FCW | None listed |
| Dec 2, 2011 | Integra LifeSciences Corp. Integra Surgical Luxtec MLX Light Source
Catalog Numbers: 00MLXAU
Product Usage: The Integra Luxtec MLX Light Source is designed to supply high intensity white light through a fiber optic cable fo Terminated |
FCW | None listed |
| Dec 2, 2011 | Integra LifeSciences Corp. Integra Surgical Luxtec MLX Light Source
Catalog Numbers: 00MLXEU Terminated |
FCW | None listed |
| Apr 25, 2011 | Integra LifeSciences Corp. Luxtec MLX 300 Watt Xenon Light Source,
Model OOMLX; Surgical/Medical Light Source
This light source is designed to supply high-intensity light to a fiber optic cable for illumination of a surgical Terminated |
FCW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.