Sunoptic Technologies
LED 9000 headlight series
4manufacturers in China registered for this device type
3catalogue 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 | Sunoptic Technologies, LLC, United States |
|---|---|
| FDA product code | HPP |
| Device type | Headlamp, Operating, Battery-Operated |
| Device class | Class 1 |
| Regulation | 21 CFR 886.4335 |
| Establishment | Contract manufacturer, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2017-05-09 |
| Record revised | 2019-02-07 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| LED 9000 Headlight Series | In distribution | |
| LED 8000 Headlight Series | In distribution | |
| LED Headlight Series 3 | 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.