Medical Illumination International, Inc
Registration 3021839632FEI 1000125341Chatsworth, CA
Owner/operator: MEDICAL ILLUMINATION INTERNATIONAL, INC.
- Manufacture Medical Device
- Repack or Relabel Medical Device
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
90days left in the window
The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 17
- Added, last 12 months
- 0
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 17
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| HPQ | IsoLED Ac=Powered LED Headlight SystemHeadlamp, Operating, Ac-Powered | Class 2 | 21 CFR 886.4335 | K102266 |
| FCT | IsoLED Portable HeadlightHeadlight, Fiberoptic Focusing | Class 2 | 21 CFR 886.4335 | — |
| HBI | OptiLux LED IlluminatorIlluminator, Fiberoptic, Surgical Field | Class 2 | 21 CFR 878.4580 | K163185 |
| HET | 1300 XSBP Xenon Light SourceLaparoscope, Gynecologic (And Accessories) | Class 2 | 21 CFR 884.1720 | K022384 |
| FSY | MI-750Light, Surgical, Ceiling Mounted | Class 2 | 21 CFR 878.4580 | K140812 |
| FST | IsoLED Ac=Powered LED Headlight SystemLight, Surgical, Fiberoptic | Class 2 | 21 CFR 878.4580 | K102266 |
| FST | IsoLux Surgical HeadlightLight, Surgical, Fiberoptic | Class 2 | 21 CFR 878.4580 | K991572 |
| FST | MI 1000Light, Surgical, Fiberoptic | Class 2 | 21 CFR 878.4580 | K100388 |
| FWB | System One Surgical Camera No AudioCamera, Television, Surgical, Without Audio | Class 1 | 21 CFR 878.4160 | — |
| KZF | MI Examination lightDevice, Medical Examination, Ac Powered | Class 1 | 21 CFR 880.6320 | — |
| LRJ | VIDASHIELD/UV24 Continuous UV-C Antimicrobial Air PurifierDisinfectant, Medical Devices | Class 1 | 21 CFR 880.6890 | — |
| KYT | IsoLED Flex Examination LightLight, Examination, Medical, Battery Powered | Class 1 | 21 CFR 880.6350 | — |
and 5 more on your full dossier
What changed
Nothing added in the last twelve months, and no change seen on the record yet.