Xenon Light Source, Models LS6180, LS6035
FDA 510(k) K982962 · Contec Medical Vision, Ltd.
510(k) numberK982962
Submission
- Device name
- Xenon Light Source, Models LS6180, LS6035
- Applicant
- Contec Medical Vision, Ltd.
Fallston,, MD, US - Received
- August 24, 1998
- Decision date
- September 23, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GCT – Light Source, Endoscope, Xenon Arc
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 876.1500
- Specialty
- Gastroenterology, Urology
Other 510(k)s with product code GCT
| 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 |
More from Designs For Vision, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K981804 | Xenon Light Source Model LS6000GCT · Traditional | 07/24/1998SE |
Questions and answers
When was Xenon Light Source, Models LS6180, LS6035 cleared by the FDA?
Xenon Light Source, Models LS6180, LS6035 (K982962) received a 510(k) decision of Substantially Equivalent on September 23, 1998, 30 days after the submission was received.
What is the product code of K982962?
The FDA product code is GCT – Light Source, Endoscope, Xenon Arc, a Class II (moderate risk) device regulated under 21 CFR 876.1500.