Medical Illumination International, Inc
Chatsworth, CA, US
Medical Illumination International, Inc appears in FDA device records in Chatsworth, CA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 5 510(k) clearances for Medical Illumination International, Inc between 2001 and 2014. The busiest year on record is 2001, with 2. The most recent is 2014, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2001 | 2 |
| 2006 | 1 |
| 2010 | 1 |
| 2014 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K140812 | MI-750 PROCEDURAL/MINOR SURGICAL LIGHT | FSY | Substantially Equivalent | |
| K100388 | 21ST CENTURY CENTURION EXCELED AND SYSTEM TWO LED LIGHTING SYSTEMS | FST | Substantially Equivalent | |
| K053227 | LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES | FST | Substantially Equivalent | |
| K010495 | CENTURA PHOTOTHERAPY SPOTLIGHT | LBI | Substantially Equivalent | |
| K003489 | NEXT GENERAL M20 SURGICAL LIGHT; NEXT GENERATION M16 MINOR SURGERY LIGHT; NEXT GENERATION SPOTLIGHT; NEXT GENERATION M8 | FSS | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3021839632 | 1000125341 | Medical Illumination International, Inc | Office, Chatsworth, CA 91311 US | 2026 | and 4 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FWBCamera, Television, Surgical, Without Audio
- KZFDevice, Medical Examination, Ac Powered
- LRJDisinfectant, Medical Devices
- HPQHeadlamp, Operating, Ac-Powered
- FCTHeadlight, Fiberoptic Focusing
- HBIIlluminator, Fiberoptic, Surgical Field
- HETLaparoscope, Gynecologic (And Accessories)
- KYTLight, Examination, Medical, Battery Powered
- FSYLight, Surgical, Ceiling Mounted
- FSTLight, Surgical, Fiberoptic
- FSSLight, Surgical, Floor Standing
- GMBLight, Wood'S, Fluorescence
- FWZOperating Room Accessories Table Tray
- FQOTable, Operating-Room, Ac-Powered
- GDCTable, Operating-Room, Electrical
- LBIUnit, Neonatal Phototherapy
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain