Product code GCT
- Device name
- Light Source, Endoscope, Xenon Arc
- Medical specialty
- Gastroenterology, Urology
- Device class
- 2
- Regulation number
- 876.1500
- Review panel
- GU
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K093125 | ALPHAXENON LIGHT 180 W AND 300 W | Gimmi GmbH | 2010-01-27 |
| K082925 | XENON-100 SCB LIGHT SOURCE, MODEL 20132620 | KARL STORZ Endoscopy-America, Inc. | 2008-12-18 |
| K070376 | CONMED LINVATEC 300W XENON LIGHT SOURCE | Conmed Linvatec | 2007-08-20 |
| K040949 | VIADUCT MINISCOPE AND ACCESSORIES | Acueity, Inc. | 2004-05-07 |
| K022490 | KSEA MEDI PACK | KARL STORZ Endoscopy-America, Inc. | 2003-09-29 |
| K031994 | LINVATEC 300W XENON LIGHT SOURCE | Linvatec Corp. | 2003-08-21 |
| K023468 | ENDOSCOPIC LIGHT SOURCE XL180/L3 | World of Medicine Lemke GmbH | 2003-01-14 |
| K021717 | ENDOSCOPIC LIGHT SOURCE, MODEL XL300/L5 | World of Medicine Lemke GmbH | 2002-08-20 |
| K020889 | ENDOSCOPIC LIGHT SOURCE XL202/L3 | World of Medicine Lemke GmbH | 2002-06-05 |
| K013880 | DAYLITE XENON LIGHT SOURCES | Designs For Vision, Inc. | 2001-12-07 |
| K992540 | XENON LIGHT SOURCE PES 1 | Laser Optik Systeme GmbH & Co. KG | 1999-09-14 |
| K992050 | LUMENON XENON LIGHT SOURCE | Walter Lorenz Surgical, Inc. | 1999-09-14 |
| K983628 | XENON LIGHT SOURCE AUTO LIP 5123, MODEL 2123.011 | Richard Wolf Medical Instruments Corp. | 1998-12-11 |
| K982962 | XENON LIGHT SOURCE, MODELS LS6180, LS6035 | Contec Medical Vision, Ltd. | 1998-09-23 |
| K981804 | XENON LIGHT SOURCE MODEL LS6000 | Contec Medical Vision, Ltd. | 1998-07-24 |
| K980281 | WELCH ALLYN XENON 300 LIGHT SOURCE | Welch Allyn, Inc. | 1998-02-27 |
| K971057 | COGENLIGHT TECHNOLOGIES XLS ILLUMINATOR SYSTEM | Cogent Light Technologies, Inc. | 1997-03-28 |
| K963227 | WHITE SUN LIGHT SOURCE MODEL #: XL300 AND #: XL175 | Products For Medicine | 1996-10-23 |
| K963044 | ENDOBEAM | Corin USA | 1996-09-20 |
| K962365 | XENON LIGHTSOURCE | Dsp Worldwide | 1996-07-18 |
| K954561 | XENON NOPPVA | KARL STORZ Endoscopy-America, Inc. | 1995-10-19 |
| K953924 | XLS-300 XENON LIGHT SOURCE | Specialties of Surgery | 1995-09-21 |
| K952028 | COLD LIGHT SOURCE LOS XL-A 100 | Laser-Optik-Systeme GmbH & Co. KG | 1995-07-27 |
| K952563 | THE TULIP LCI-200 ILLUMINATION & IMAGING SYSTEM | The Tulip Mfg. Co. | 1995-07-25 |
| K952696 | XENON LIGHT SOURCE MODEL 5121 | Richard Wolf Medical Instruments Corp. | 1995-07-25 |
| K951895 | ACCU-BEAM 300W XENON LIGHT SOURCE | Tti Medical | 1995-05-24 |
| K951971 | XENON LIGHT SOURCE | Envision Medical Corp. | 1995-05-24 |
| K944607 | MODEL 5135 AUTO LP/FLASH | Richard Wolf Medical Instruments Corp. | 1994-12-13 |
| K944821 | MODEL 5151 | Richard Wolf Medical Instruments Corp. | 1994-11-14 |
| K934559 | KARL STORZ XENON LIGHT SOURCE MODEL 201320-20 | KARL STORZ Endoscopy-America, Inc. | 1994-04-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10845854080634 | CONMED | Conmed Corporation | 2026-03-24 |
| 10845854041291 | CONMED | Conmed Corporation | 2026-03-24 |
| 00840183528607 | BR Surgical, LLC | BR Surgical, LLC | 2024-10-24 |
| 04048551057261 | n.a. | Karl Storz GmbH & Co. KG | 2024-10-16 |
| 00857556008543 | BR Surgical, LLC | BR Surgical, LLC | 2024-07-22 |
| 00857556008475 | BR Surgical, LLC | BR Surgical, LLC | 2024-07-22 |
| 00857556008468 | BR Surgical, LLC | BR Surgical, LLC | 2024-07-22 |
| 10845854041314 | CONMED | Conmed Corporation | 2023-12-04 |
| 10845854041307 | CONMED | Conmed Corporation | 2023-12-04 |
| 04961333083701 | PENTAX | HOYA CORPORATION | 2023-07-31 |
| 04250369707348 | ILO | ILO electronic GmbH | 2023-06-22 |
| 04250369707324 | ILO | ILO electronic GmbH | 2023-06-22 |
| 04250369707317 | ILO | ILO electronic GmbH | 2023-06-22 |
| 04250369707355 | ILO | ILO electronic GmbH | 2023-06-22 |
| 04250369707362 | ILO | ILO electronic GmbH | 2023-06-22 |
| 04048551346266 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551346273 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551346303 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551325995 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04048551166116 | n.a. | Karl Storz GmbH & Co. KG | 2019-02-23 |
| 04961333228188 | PENTAX | HOYA CORPORATION | 2017-04-07 |
| 20845854027445 | NA | Conmed Corporation | 2016-09-24 |
| 20845854080631 | CONMED | Conmed Corporation | 2016-09-24 |
| 20845854041335 | NA | Conmed Corporation | 2016-09-24 |
| 04048551405680 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551272008 | TELE PACK | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551271995 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551060841 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04048551166123 | n.a. | Karl Storz GmbH & Co. KG | 2016-09-23 |
| 04953170216985 | LIGHT CONTROL CABLE | OLYMPUS MEDICAL SYSTEMS CORP. | 2016-09-21 |