Power Dental USA
DR. Kim's Headlight - Viewfiender, Pedal, AND Autofocus
4manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (1), Jiangsu (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Alltion (Guangxi) Instrument Co., Ltd. | Wuzhou | Guangxi | Manufacturer | 8 |
| Nanjing Yanan Special Lighting Factory | Nanjing | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Power Dental U.S.A. Inc. |
|---|---|
| FDA product code | HPP |
| Device type | Headlamp, Operating, Battery-Operated |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4335 |
| Premarket notification | Exempt |
| Record published | 2022-07-12 |
| Record revised | 2025-12-09 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Distribution end date | 2022-06-17 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| KIM-7 | In distribution | |
| KIM-9 | In distribution | |
| NDKLAMP-5 | In distribution | |
| KIM-12 | In distribution | |
| NDKLAMP-1 | In distribution | |
| KIMV-2 | In distribution | |
| KIMV | In distribution | |
| KIMS-BK | In distribution | |
| KIM-2 | In distribution | |
| KIMV-1 | In distribution | |
| KIM-8 | In distribution | |
| NDKLAMP-3 | In distribution | |
| KIM-5 | In distribution | |
| DCAM3 | In distribution | |
| KIM-1 | In distribution | |
| KIM-3 | In distribution | |
| NDKLAMP-8 | In distribution | |
| DCAM | In distribution | |
| KIM-24 | In distribution | |
| KIM-4 | In distribution | |
| KIMS-GY | In distribution | |
| NDKLAMP | Withdrawn | |
| NDKLAMP-4 | Withdrawn | |
| NDKLAMP-6 | Withdrawn | |
| NDKLAMP-7 | Withdrawn | |
| NDKLAMP-2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Enova Illumination | Enova Illumination, Inc | 79 |
| MedLED Chrome | Riverpoint Medical LLC | 41 |
| Jedmed | Jedmed Instrument Company | 28 |
| MedLED Spectra | Riverpoint Medical LLC | 27 |
| MedLED | Riverpoint Medical LLC | 19 |
| Quasar | Enova Illumination, Inc | 12 |
| Qosmic | Enova Illumination, Inc | 11 |
| BR Surgical, LLC | BR Surgical LLC | 10 |
| Quantum | Enova Illumination, Inc | 10 |
| MaxLite Elite | Riverpoint Medical LLC | 10 |
| Headlamp, Operating, Battery-Operated | Enova Illumination, Inc | 8 |
| MedLED Face Shield | Riverpoint Medical LLC | 8 |
Showing 12 of 68. All products under Headlamp, Operating, Battery-Operated
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.