Data / Medical devices / United States / Medical Illumination International, Inc
Medical Illumination International, Inc: FDA-registered device maker in Chatsworth, CA, United States, 6 510(k) clearances
Medical Illumination International, Inc is registered with the FDA (registration 3021839632) in Chatsworth, CA, United States. It lists 14 device types. The FDA files 6 510(k) clearances under its listings, the newest dated November 21, 2016. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3021839632
- FEI number
- 1000125341
- Address
- Office 19749 Dearborn Street, Chatsworth, CA, United States, 91311
- Owner or operator
- MEDICAL ILLUMINATION INTERNATIONAL, INC. (9003847)
- Roles
- Manufacturer, Repackager or relabeler
- First device listed
- June 26, 1992
- Registered through
- 2026
- Brand names listed
- 1300 XSBP Xenon Light Source, CENTURY DIAGNOSTIC LIGHT, IsoLED Ac=Powered LED Headlight System, IsoLED Flex Examination Light, IsoLED Portable Headlight, IsoLux Surgical Headlight, MI 1000, MI Examination light and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 21, 2016 | K163185 | OptiLux LED Illuminator | HBI | Substantially Equivalent | Isolux, LLC | accessdata.fda.gov |
| August 7, 2014 | K140812 | MI-750 PROCEDURAL/MINOR SURGICAL LIGHT | FSY | Substantially Equivalent | Medical Illumination International, Inc. | accessdata.fda.gov |
| September 24, 2010 | K102266 | ISOLED AC-POWERED LED HEADLIGHT SYSTEM | FST | Substantially Equivalent | Isolux, LLC | accessdata.fda.gov |
| June 22, 2010 | K100388 | 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS | FST | Substantially Equivalent | Medical Illumination International, Inc. | accessdata.fda.gov |
| October 18, 2002 | K022384 | XENON FIBEROPTIC LIGHT SOURCE, MODEL 1300 XSBP | HET | Substantially Equivalent | Isolux America | accessdata.fda.gov |
| July 8, 1999 | K991572 | ISOLUX SURGICAL HEADLIGHT | FST | Substantially Equivalent | Isolux America | accessdata.fda.gov |
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Updated November 21, 2016. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.