VLS 5300 300W Xenon Light Source
FDA 510(k) K904681 · Vistek Corp.
510(k) numberK904681
Submission
- Device name
- VLS 5300 300W Xenon Light Source
- Applicant
- Vistek Corp.
Goleta, CA, US - Received
- October 15, 1990
- Decision date
- December 18, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- HBI – Illuminator, Fiberoptic, Surgical Field
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
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|---|---|---|---|
| K223183 | Light-Guide CablesHBI · Traditional | Olympus Winter & Ibe GmbH | 01/13/2023SE |
| K163185 | OptiLux LED IlluminatorHBI · Traditional | Isolux, LLC | 11/21/2016SE |
| K141781 | Kogent Spetzler Lighted Suction TubesHBI · Traditional | Katalyst Surgical, LLC | 04/09/2015SE |
| K111342 | Light Guide CableHBI · Traditional | Schott North America | 11/25/2011SE |
| K052979 | 1125 XSB Xenon Fiber-Optic Light SourceHBI · Traditional | Isolux, LLC | 10/31/2005SE |
| K021931 | Endoscopic Fiberoptic CableHBI · Traditional | Gulf Medical Fiberoptics | 09/06/2002SE |
| K991208 | Endoscopic Fiberoptic CableHBI · Traditional | Isolux America | 06/23/1999SE |
| K983277 | Lightsource or Illuminator Model I-100HBI · Traditional | Cuda Products Co. | 12/16/1998SE |
| K933593 | Luminous 150 Fiberoptic IlluminatorHBI · Traditional | Progressive Dynamics, Inc. | 10/28/1993SE |
| K922837 | S1500 Xenon Light SourceHBI · Traditional | Endomedix | 11/03/1992SE |
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Questions and answers
When was VLS 5300 300W Xenon Light Source cleared by the FDA?
VLS 5300 300W Xenon Light Source (K904681) received a 510(k) decision of Substantially Equivalent on December 18, 1990, 64 days after the submission was received.
What is the product code of K904681?
The FDA product code is HBI – Illuminator, Fiberoptic, Surgical Field, a Class II (moderate risk) device regulated under 21 CFR 878.4580.