XENON LIGHT SOURCE
FDA 510(k) clearance K904609 · decided 1990-12-18
Clearance details
- K-number
- K904609
- Device name
- XENON LIGHT SOURCE
- Applicant
- Medical Dynamics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1990-10-11
- Decision date
- 1990-12-18
- Days to decision
- 68 days
- Clearance type
- Traditional
- Product code
- HBI
- Device class
- 2
- Regulation number
- 878.4580
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- Location
- Englewood, CO, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Light-Guide Cables (K223183) | Olympus Winter & Ibe GmbH | 2023-01-13 |
| OptiLux LED Illuminator (K163185) | Isolux, LLC | 2016-11-21 |
| KOGENT SPETZLER LIGHTED SUCTION TUBES (K141781) | Katalyst Surgical, LLC | 2015-04-09 |
| LIGHT GUIDE CABLE (K111342) | Schott North America | 2011-11-25 |
| 1125 XSB XENON FIBER-OPTIC LIGHT SOURCE (K052979) | Isolux, LLC | 2005-10-31 |
| ENDOSCOPIC FIBEROPTIC CABLE (K021931) | Gulf Medical Fiberoptics | 2002-09-06 |
| ENDOSCOPIC FIBEROPTIC CABLE (K991208) | Isolux America | 1999-06-23 |
| LIGHTSOURCE OR ILLUMINATOR MODEL I-100 (K983277) | Cuda Products Co. | 1998-12-16 |
| LUMINOUS 150 FIBEROPTIC ILLUMINATOR (K933593) | Progressive Dynamics, Inc. | 1993-10-28 |
| S1500 XENON LIGHT SOURCE (K922837) | Endomedix | 1992-11-03 |
| NEXTEC FIBEROPTIC CABLES (K922462) | Nextec Corp. | 1992-09-21 |
| LUMINOUS 250 FIBEROPTIC ILLUMINATOR (K921866) | Progressive Dynamics, Inc. | 1992-07-08 |
Recalls involving this device
No recalls on record reference this clearance.