Data / Medical devices / United States / Enova Illumination, Inc
Enova Illumination, Inc: FDA-registered device maker in Minneapolis, MN, United States, 3 510(k) clearances
Enova Illumination, Inc is registered with the FDA (registration 2127132) in Minneapolis, MN, United States. It lists 10 device types. The FDA files 3 510(k) clearances under its listings, the newest dated May 10, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 2127132
- Address
- 6305 Sandburg Rd. Suite 100, Minneapolis, MN, United States, 55427
- Owner or operator
- Enova Illumination Inc. (2127132)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 10, 2006
- Registered through
- 2026
- Brand names listed
- AC-VUE 2.5, MDA-Vue 2.8, SM-Vue 2.8, MD-Vue 2.8, XG-Vue 2.8, XG-Vue 3.8, Activ Battery, Activ Elite Battery, Apex Locater, Axis Elite Light, Axis Light, Broken Removal Kit 17mm, Broken Removal Kit 21mm, and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Drill, Bone, Powered | DZI | 2 | Complaint file establishment | accessdata.fda.gov |
| Handpiece, Direct Drive, Ac-Powered | EKX | 1 | Complaint file establishment | accessdata.fda.gov |
| Headlamp, Operating, Battery-Operated | HPP | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Instrument, Hand, Calculus Removal | ELA | 1 | Complaint file establishment | accessdata.fda.gov |
| Locator, Root Apex | LQY | U | Complaint file establishment | accessdata.fda.gov |
| Loupe, Diagnostic/Surgical | FSP | 1 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Microscope, Surgical, General & Plastic Surgery | FSO | 1 | Complaint file establishment | accessdata.fda.gov |
| Mirror, Mouth | EAX | 1 | Complaint file establishment | accessdata.fda.gov |
| Plugger, Root Canal, Endodontic | EKR | 1 | Complaint file establishment | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Complaint file establishment | accessdata.fda.gov |
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 |
|---|---|---|---|---|---|---|
| May 10, 2021 | K203320 | Endo Motor | EKX | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| December 18, 2018 | K181087 | Apex Locator, DPEX III | LQY | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
| November 18, 2011 | K111290 | PIEZO BONE SURGERY | DZI | Substantially Equivalent | Guilin Woodpecker Medical Instrument Co., Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Headlamp, Operating, Battery-Operated
- All makers of Locator, Root Apex
- All makers of Handpiece, Direct Drive, Ac-Powered
- All makers of Scaler, Ultrasonic
- All makers of Drill, Bone, Powered
- All makers of Mirror, Mouth
Updated May 10, 2021. 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.