Light Source, Endoscope, Xenon Arc
FDA product code GCT · Class II (moderate risk) · 21 CFR 876.1500 · Gastroenterology, Urology
47510(k) clearances
0PMA approvals
2recalls
Manufacturers
- Richard Wolf Medical Instruments Corp. 4
- KARL STORZ Endoscopy-America, Inc. 4
- World of Medicine Lemke GmbH 3
- Laser-Optik-Systeme GmbH & Co. KG 2
- Contec Medical Vision, Ltd. 2
- Welch Allyn, Inc. 2
- Cogent Light Technologies, Inc. 2
- Pentax Precision Instrument Corp. 2
- Surgeon Surgical Instrumentation, Inc. 1
- Tti Medical 1
- Carl Zeiss, Inc. 1
- Endosurgical Development Corp. 1
- Angiolaz, Inc. 1
- Cabot Medical Corp. 1
- Coopervision Surgical 1
- Gimmi GmbH 1
- Perkinelmer Optoelectronics 1
- United States Endoscopy Group, Inc. 1
- Frantz Medical Development, Ltd. 1
- Red Wing Imaging, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K093125 | Alphaxenon Light 180 W and 300 WGCT · Abbreviated | Gimmi GmbH | 01/27/2010SE |
| K082925 | XENON-100 SCB Light Source, Model 20132620GCT · Traditional | KARL STORZ Endoscopy-America, Inc. | 12/18/2008SE |
| K070376 | Conmed Linvatec 300W Xenon Light SourceGCT · Traditional | Conmed Linvatec | 08/20/2007SE |
| K040949 | Viaduct Miniscope and AccessoriesGCT · Traditional | Acueity, Inc. | 05/07/2004SE |
| K022490 | Ksea Medi PackGCT · Traditional | KARL STORZ Endoscopy-America, Inc. | 09/29/2003SE |
| K031994 | Linvatec 300W Xenon Light SourceGCT · Traditional | Linvatec Corp. | 08/21/2003SE |
| K023468 | Endoscopic Light Source XL180/L3GCT · Traditional | World of Medicine Lemke GmbH | 01/14/2003SE |
| K021717 | Endoscopic Light Source, Model XL300/L5GCT · Traditional | World of Medicine Lemke GmbH | 08/20/2002SE |
| K020889 | Endoscopic Light Source XL202/L3GCT · Traditional | World of Medicine Lemke GmbH | 06/05/2002SE |
| K013880 | Daylite Xenon Light SourcesGCT · Traditional | Designs For Vision, Inc. | 12/07/2001SE |
| K992540 | Xenon Light Source Pes 1GCT · Traditional | Laser Optik Systeme GmbH & Co. KG | 09/14/1999SE |
| K992050 | Lumenon Xenon Light SourceGCT · Traditional | Walter Lorenz Surgical, Inc. | 09/14/1999SE |
| K983628 | Xenon Light Source Auto Lip 5123, Model 2123.011GCT · Traditional | Richard Wolf Medical Instruments Corp. | 12/11/1998SE |
| K982962 | Xenon Light Source, Models LS6180, LS6035GCT · Traditional | Contec Medical Vision, Ltd. | 09/23/1998SE |
| K981804 | Xenon Light Source Model LS6000GCT · Traditional | Contec Medical Vision, Ltd. | 07/24/1998SE |
| K980281 | Welch Allyn Xenon 300 Light SourceGCT · Traditional | Welch Allyn, Inc. | 02/27/1998SE |
| K971057 | Cogenlight Technologies XLS Illuminator SystemGCT · Traditional | Cogent Light Technologies, Inc. | 03/28/1997SE |
| K963227 | White Sun Light Source Model #: XL300 and #: XL175GCT · Traditional | Products For Medicine | 10/23/1996SE |
| K963044 | EndobeamGCT · Traditional | Corin USA | 09/20/1996SE |
| K962365 | Xenon LightsourceGCT · Traditional | Dsp Worldwide | 07/18/1996SE |
| K954561 | Xenon NoppvaGCT · Traditional | KARL STORZ Endoscopy-America, Inc. | 10/19/1995SE |
| K953924 | XLS-300 Xenon Light SourceGCT · Traditional | Specialties of Surgery | 09/21/1995SE |
| K952028 | Cold Light Source Los Xl-A 100GCT · Traditional | Laser-Optik-Systeme GmbH & Co. KG | 07/27/1995SE |
| K952696 | Xenon Light Source Model 5121GCT · Traditional | Richard Wolf Medical Instruments Corp. | 07/25/1995SE |
| K952563 | The Tulip LCI-200 Illumination & Imaging SystemGCT · Traditional | The Tulip Mfg. Co. | 07/25/1995SE |
| K951971 | Xenon Light SourceGCT · Traditional | Envision Medical Corp. | 05/24/1995SE |
| K951895 | Accu-Beam 300W Xenon Light SourceGCT · Traditional | Tti Medical | 05/24/1995SE |
| K944607 | Model 5135 Auto Lp/FlashGCT · Traditional | Richard Wolf Medical Instruments Corp. | 12/13/1994SE |
| K944821 | Model 5151GCT · Traditional | Richard Wolf Medical Instruments Corp. | 11/14/1994SE |
| K934559 | Karl Storz Xenon Light Source Model 201320-20GCT · Traditional | KARL STORZ Endoscopy-America, Inc. | 04/22/1994SE |
| K940270 | LCI-100 and LCI-200 Welch Allyn Illumination and Imaging SystemGCT · Traditional | Welch Allyn, Inc. | 04/20/1994SE |
| K936198 | Zeiss Superlux High-Intensity Light SourcesGCT · Traditional | Carl Zeiss, Inc. | 04/06/1994SE |
| K933405 | Cogent Light Illuminator 10010 Xenon Light SourceGCT · Traditional | Cogent Light Technologies, Inc. | 02/18/1994SE |
| K935423 | Cool Light 300GCT · Traditional | Endosurgical Development Corp. | 01/26/1994SE |
| K933868 | Angiolaz Video Endoscopic System Model CAMLUM1 and AccessoriesGCT · Traditional | Angiolaz, Inc. | 11/10/1993SE |
| K932281 | Verres NeedleGCT · Traditional | Surgeon Surgical Instrumentation, Inc. | 08/06/1993SE |
| K924897 | Xenon Endoscopic Illuminator, Model XEI-300GCT · Traditional | Medical Devices, Inc. | 07/06/1993SE |
| K921315 | Pentax Xenon Light SourceGCT · Traditional | Pentax Precision Instrument Corp. | 06/25/1993SE |
| K923210 | System 3000 Xenon Videolap LightGCT · Traditional | Cabot Medical Corp. | 10/05/1992SE |
| K921390 | Xenon Light Source and AccessoriesGCT · Traditional | Coopervision Surgical | 07/27/1992SE |
| K913586 | Marlow Verres NeedlesGCT · Traditional | Marlo Surgical Technology | 10/08/1991SE |
| K912354 | Olymous XLS Xenon Light SourceGCT · Traditional | Perkinelmer Optoelectronics | 08/16/1991SE |
| K911492 | Endoscopic Light SourceGCT · Traditional | United States Endoscopy Group, Inc. | 08/14/1991SE |
| K905282 | Endoscopic Accessory to the Light SourceGCT · Traditional | Frantz Medical Development, Ltd. | 03/19/1991SEKD |
| K905124 | Multiple Imaging Xenon Arc Auto Ligh SourceGCT · Traditional | Red Wing Imaging, Inc. | 01/25/1991SE |
| K864801 | The Keymed Hi-Light 250 Light SourceGCT · Traditional | Keymed, Inc. | 12/24/1986SE |
| K792215 | Pentex Upper G.I. Scope Model FG-28AGCT · Traditional | Pentax Precision Instrument Corp. | 12/10/1979SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-2456-2012 Class II | ***REF LS7700***Qty 1*** EC REP*** ConMed Linvatec Xenon Universal Light SourceLinvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon… | Linvatec Corp. dba ConMed Linvatec | 05/20/2011Terminated |
| Z-2455-2012 Class II | ***REF LS7600***Qty 1*** EC REP*** ConMed Linvatec Xenon Light SourceLinvatec Corporation dba ConMed Linvatec, Largo, FL initiated a recall of their products LS7700 Xenon… | Linvatec Corp. dba ConMed Linvatec | 05/20/2011Terminated |