The following data is part of a premarket notification filed by Medical Illumination, Inc. with the FDA for Illuminator Viii Ultra/spot.
| Device ID | K922282 |
| 510k Number | K922282 |
| Device Name: | ILLUMINATOR VIII ULTRA/SPOT |
| Classification | Device, Medical Examination, Ac Powered |
| Applicant | MEDICAL ILLUMINATION, INC. 12734 BRANFORD ST. UNIT 1 & 2 Arleta, CA 91331 |
| Product Code | KZF |
| CFR Regulation Number | 880.6320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-05-15 |
| Decision Date | 1993-03-04 |