Light Source, Fiberoptic, Routine
FDA product code FCW · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
31510(k) clearances
0PMA approvals
5recalls
Manufacturers
- Pilling Co. 2
- KARL STORZ Endoscopy-America, Inc. 2
- Luxtec Corp. 2
- Welch Allyn, Inc. 2
- Corin USA 1
- V. Mueller O.V. Baxter Healthcare Corp. 1
- Novaprobe Incorporated 1
- Circon Video 1
- Videolabs, Inc. 1
- Fiber Imaging Technologies, Inc. 1
- Angiolaz, Inc. 1
- Urohealth, Inc. 1
- Iba/Griffith 1
- Tridak Division of Indicon, Inc. 1
- Stephen Chakoff, Inc. 1
- Servicetrends, Inc. 1
- United States Surgical, A Division of Tyco Healthc 1
- Cuda Products Co. 1
- Storz Instrument Co. 1
- Orlux Engineering and Instrumentation 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K131226 | Novaprobe LED Light SourceFCW · Traditional | Novaprobe Incorporated | 07/24/2014SE |
| K123956 | Power LED 175FCW · Traditional | KARL STORZ Endoscopy-America, Inc. | 01/25/2013SE |
| K123359 | OVS1 Video SystemFCW · Traditional | Olive Medical Corp. | 12/19/2012SE |
| K121724 | Endolight LED 1.1 Endolightled 1.2FCW · Traditional | Richard Wolf Medical Instruments Corp. | 09/20/2012SE |
| K093792 | LED Light SourceFCW · Traditional | Sunoptic Technologies, LLC | 03/18/2010SE |
| K091968 | Karl Storz LED Nova 100 Cold Light Fountain, Models 2016020, 20161020CFCW · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/14/2009SE |
| K082813 | Stryker LED LightsourceFCW · Traditional | Stryker Corp. | 12/19/2008SE |
| K081477 | Luxtec MLX Light SourceFCW · Traditional | Integra Luxtec, Inc. | 06/18/2008SE |
| K032430 | Acueity Medical Light SourceFCW · Traditional | Acueity, Inc. | 09/05/2003SE |
| K012265 | Metal Halide Light Source, Models MV-9088-T, MV-9088FCW · Traditional | Circon Video | 10/17/2001SE |
| K000229 | Videolabs Medcam Proplus Video Camera and Integral Light SourceFCW · Traditional | Videolabs, Inc. | 03/21/2000SE |
| K993300 | Coldlightsource PL3000FCW · Traditional | Fiber Imaging Technologies, Inc. | 11/05/1999SE |
| K992447 | 50 W Metal Halide Illuminator, Ves 0501.FCW · Traditional | Angiolaz, Inc. | 10/20/1999SE |
| K970598 | Integrated Visualization SystemFCW · Traditional | Urohealth, Inc. | 03/12/1997SE |
| K964586 | Prescott's Light Source Model No. II-150FCW · Traditional | Iba/Griffith | 01/17/1997SE |
| K963043 | EndospotFCW · Traditional | Corin USA | 09/20/1996SE |
| K951647 | Welch Allyn Hi - Lux IlluminatorFCW · Traditional | Welch Allyn, Inc. | 05/17/1995SE |
| K945420 | Chakoff EndoscopyFCW · Traditional | Stephen Chakoff, Inc. | 12/08/1994SE |
| K942155 | HMT Endoscreen, Model Esc 501FCW · Traditional | Servicetrends, Inc. | 07/01/1994SE |
| K934531 | Auto Suture Disposable Light CableFCW · Traditional | United States Surgical, A Division of Tyco Healthc | 05/18/1994SE |
| K933369 | Cuda Products Corp. LightsourcesFCW · Traditional | Cuda Products Co. | 01/03/1994SE |
| K905376 | Storz S6000 Light SourceFCW · Traditional | Storz Instrument Co. | 01/23/1991SE |
| K903790 | Endoscopic Light Source 250 EndoFCW · Traditional | Orlux Engineering and Instrumentation | 12/07/1990SE |
| K890716 | Luxtec Aco Series 4000 Light SourceFCW · Traditional | Luxtec Corp. | 04/26/1989SE |
| K864385 | Luxtec Light SourcesFCW · Traditional | Luxtec Corp. | 01/13/1987SE |
| K852951 | Welch Allyn Fiber Optic Cables Various ModelsFCW · Traditional | Welch Allyn, Inc. | 08/27/1985SE |
| K842609 | R.L. Medical Twin Light SourceFCW · Traditional | Tridak Division of Indicon, Inc. | 08/09/1984SE |
| K832807 | Pediatric Illuminating UreteralFCW · Traditional | Van-Tec, Inc. | 10/19/1983SE |
| K771739 | Pentax LH-150F Light SourceFCW · Traditional | Pilling Co. | 09/30/1977SE |
| K760647 | Adapter, Fiber Optics HeadlightFCW · Traditional | Pilling Co. | 12/06/1976SE |
| K760176 | Floorstand, Fiber Optic Light SourceFCW · Traditional | V. Mueller O.V. Baxter Healthcare Corp. | 08/30/1976SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1474-2023 Class II | SafeLight Fiber Optic Cable: Clear, 5MM X 10FT 3.05M, REF: 0233-050-100; Gray, 5MM X…Fiber optic cables assembled with not enough epoxy on the proximal end, creating light output issues, which… | Stryker Corporation | 03/02/2023Open, Classified |
| Z-0358-2012 | Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXEUA loose screw may result in shifting of components and improper function of the turret or actuator assembly. | Integra LifeSciences Corp. | 10/14/2011Terminated |
| Z-0357-2012 | Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLXAU Product Usage: The…A loose screw may result in shifting of components and improper function of the turret or actuator assembly. | Integra LifeSciences Corp. | 10/14/2011Terminated |
| Z-0356-2012 | Integra Surgical Luxtec MLX Light Source Catalog Numbers: 00MLX Product Usage: The…A loose screw may result in shifting of components and improper function of the turret or actuator assembly. | Integra LifeSciences Corp. | 10/14/2011Terminated |
| Z-2060-2011 | Luxtec MLX 300 Watt Xenon Light Source, Model OOMLX; Surgical/Medical Light Source This…Malfunction of the MLX Control Board may cause loss of manual control and Lamp shut down. | Integra LifeSciences Corp. | 03/07/2011Terminated |