Spot-On 2 LED Headlight
Illuminate the oral cavity without blinding your patient. Spring clip mount fits most eyewear. Loupe mount also included. Continuously adjustable spot size, from 0.6" dia. to 3" dia. at a…
Illuminate the oral cavity without blinding your patient. Spring clip mount fits most eyewear. Loupe mount also included. Continuously adjustable spot size, from 0.6″ dia. to 3″ dia. at a working distance of 14″. XY-adjustable light mount directs illumination exactly where you need it. Eight brightness levels to suit varying lighting needs. Long-lasting LED bulb provides crisp, white light. Sharp, circular focus eliminates perimeter “halos.” Weighs only 0.8 oz. (without cord or battery). Specifications: Operating time: 2-1/2 hours on one six-hour charge. Spot diameter: 0.6″-3″ at 14″ working distance. Lamp weight: 0.8 oz. (without cord or battery). Light intensity: adjustable up to 23,000 lux. Color temp.: 6,000K (±1,000). Battery: 2,600mAh rechargeable Lithium. System includes 5V charger, spring clip mount, loupe mount, two battery packs, clip-on leather battery case, cord clips, and padded storage case. One year warranty.
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 | Practicon, Inc., United States |
|---|---|
| FDA product code | HPP |
| Device type | Headlamp, Operating, Battery-Operated |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4335 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-07-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 08264B | In distribution |
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 |
| Power Dental USA | Power Dental U.S.A. Inc. | 26 |
| 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 |
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.