LUXTEC MLX LIGHT SOURCE
FDA 510(k) clearance K081477 · decided 2008-06-18
Clearance details
- K-number
- K081477
- Device name
- LUXTEC MLX LIGHT SOURCE
- Applicant
- Integra Luxtec, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2008-05-27
- Decision date
- 2008-06-18
- Days to decision
- 22 days
- Clearance type
- Traditional
- Product code
- FCW
- Device class
- 2
- Regulation number
- 876.1500
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- West Boylston, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Integra Luxtec
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| NOVAPROBE LED LIGHT SOURCE (K131226) | Novaprobe Incorporated | 2014-07-24 |
| POWER LED 175 (K123956) | KARL STORZ Endoscopy-America, Inc. | 2013-01-25 |
| OVS1 VIDEO SYSTEM (K123359) | Olive Medical Corp. | 2012-12-19 |
| ENDOLIGHT LED 1.1 ENDOLIGHTLED 1.2 (K121724) | Richard Wolf Medical Instruments Corp. | 2012-09-20 |
| LED LIGHT SOURCE (K093792) | Sunoptic Technologies, LLC | 2010-03-18 |
| KARL STORZ LED NOVA 100 COLD LIGHT FOUNTAIN, MODELS 2016020, 20161020C (K091968) | KARL STORZ Endoscopy-America, Inc. | 2009-09-14 |
| STRYKER LED LIGHTSOURCE (K082813) | Stryker Corp. | 2008-12-19 |
| ACUEITY MEDICAL LIGHT SOURCE (K032430) | Acueity, Inc. | 2003-09-05 |
| METAL HALIDE LIGHT SOURCE, MODELS MV-9088-T, MV-9088 (K012265) | Circon Video | 2001-10-17 |
| VIDEOLABS MEDCAM PROPLUS VIDEO CAMERA AND INTEGRAL LIGHT SOURCE (K000229) | Videolabs, Inc. | 2000-03-21 |
| COLDLIGHTSOURCE PL3000 (K993300) | Fiber Imaging Technologies, Inc. | 1999-11-05 |
| 50 W METAL HALIDE ILLUMINATOR, VES 0501. (K992447) | Angiolaz, Inc. | 1999-10-20 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLX Product Usage: The Integra recall (Z-0356-2012) | Integra LifeSciences Corp. | 2011-12-02 |
| Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXAU Product Usage: The Integ recall (Z-0357-2012) | Integra LifeSciences Corp. | 2011-12-02 |
| Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEU recall (Z-0358-2012) | Integra LifeSciences Corp. | 2011-12-02 |
| Luxtec MLX 300 Watt Xenon Light Source, Model OOMLX; Surgical/Medical Light Source This li recall (Z-2060-2011) | Integra LifeSciences Corp. | 2011-04-25 |