Luminous 250 Fiberoptic Illuminator
FDA 510(k) K921866 · Progressive Dynamics, Inc.
510(k) numberK921866
Submission
- Device name
- Luminous 250 Fiberoptic Illuminator
- Applicant
- Progressive Dynamics, Inc.
Marshall, MI, US - Received
- April 20, 1992
- Decision date
- July 8, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- HBI – Illuminator, Fiberoptic, Surgical Field
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4580
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code HBI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
More from Endomedix
| 510(k) | Device | Decision |
|---|---|---|
| K952329 | Life-Air 1000 Hypothermic Therapy SystemDWJ · Traditional | 01/17/1996SE |
| K944688 | Luminous 150 Dual Lampfiberoptic IlluminatorFFS · Traditional | 11/01/1994SE |
| K933764 | Life-Air 1000 Patient Warming CoverDWJ · Traditional | 11/09/1993SE |
| K933593 | Luminous 150 Fiberoptic IlluminatorHBI · Traditional | 10/28/1993SE |
| K914382 | Life-Air 1000 Hypothermic Treatment SystemDWJ · Traditional | 04/21/1992SE |
| K914383 | Life-Air 1000 Patient Warming CoversDWJ · Traditional | 03/30/1992SE |
Questions and answers
When was Luminous 250 Fiberoptic Illuminator cleared by the FDA?
Luminous 250 Fiberoptic Illuminator (K921866) received a 510(k) decision of Substantially Equivalent on July 8, 1992, 79 days after the submission was received.
What is the product code of K921866?
The FDA product code is HBI – Illuminator, Fiberoptic, Surgical Field, a Class II (moderate risk) device regulated under 21 CFR 878.4580.