The following data is part of a premarket notification filed by Medical Illumination International, Inc. with the FDA for Luxenon 150-300 Watt Medical Fiberoptic Light Source Illuminating Headlights, Spotlights, Refractors And Endoscopes.
| Device ID | K053227 |
| 510k Number | K053227 |
| Device Name: | LUXENON 150-300 WATT MEDICAL FIBEROPTIC LIGHT SOURCE ILLUMINATING HEADLIGHTS, SPOTLIGHTS, REFRACTORS AND ENDOSCOPES |
| Classification | Light, Surgical, Fiberoptic |
| Applicant | MEDICAL ILLUMINATION INTERNATIONAL, INC. 547 LIBRARY ST. San Fernando, CA 91340 |
| Contact | Mike Alcala |
| Correspondent | Mike Alcala MEDICAL ILLUMINATION INTERNATIONAL, INC. 547 LIBRARY ST. San Fernando, CA 91340 |
| Product Code | FST |
| CFR Regulation Number | 878.4580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-11-17 |
| Decision Date | 2006-01-13 |
| Summary: | summary |