Enova Illumination
Quasar Warm Standard LED Headlight System Contains the following items, by Enova part number and UDI: Part Name Part No. UDI Quasar Warm lamp 80087 00850025993555 Carrying Case 80034-001…
Quasar Warm Standard LED Headlight System Contains the following items, by Enova part number and UDI: Part Name Part No. UDI Quasar Warm lamp 80087 00850025993555 Carrying Case 80034-001 00850025993678 PP2 80200-001 00850025993609 Black Extension Cable 80303-001 00850025993708 Battery Belt 80500-001 00850025993722 Single Charger 80101-001 00850025993623 C-13 Power Cord (Type B)* 80150-001 00850025993739 C-13 Power Cord (Type C)* 80150-00C 00810186670214 C-13 Power Cord (Type G)* 80150-00G 00810186670139 C-13 Power Cord (Type I)* 80150-00I 00810186670207 *One power cord per system; style depends on region to which the unit is sold.
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 | Enova Illumination, 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, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-01-27 |
| Record revised | 2023-05-03 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 80800-001 | In distribution | |
| 800071-002 | In distribution | |
| 80801-003 | In distribution | |
| 90093-001 | In distribution | |
| 90097-001 | In distribution | |
| 99999-003 | In distribution | |
| 80150-001 | In distribution | |
| 80203-001 | In distribution | |
| 800070 | In distribution | |
| 90096-XX1 | In distribution | |
| 90097-002 | In distribution | |
| 90093-004 | In distribution | |
| 80305-001 | In distribution | |
| 80096 | In distribution | |
| 80201-001 | In distribution | |
| 80801-002 | In distribution | |
| 90095-001 | In distribution | |
| 80205-001 | In distribution | |
| 80095 | In distribution | |
| 80301-001 | In distribution | |
| 80097 | In distribution | |
| 80801-005 | In distribution | |
| 90095-003 | In distribution | |
| 80200-001 | In distribution | |
| 80304-004 | In distribution | |
| 80084 | In distribution | |
| 80150-00G | In distribution | |
| 80090 | In distribution | |
| 80800-002 | In distribution | |
| 90092-002 | In distribution | |
| 80302-001 | In distribution | |
| 80034-001 | In distribution | |
| 80801-007 | In distribution | |
| 80087 | In distribution | |
| 80204 | In distribution | |
| 90096-XX3 | In distribution | |
| 80085 | In distribution | |
| 80800-003 | In distribution | |
| 80500-001 | In distribution | |
| 800071-001 | In distribution | |
| 90092-001 | In distribution | |
| 90092-003 | In distribution | |
| 90092-004 | In distribution | |
| 80094 | In distribution | |
| 80150-00I | In distribution | |
| 80205-001 | In distribution | |
| 80098 | In distribution | |
| 99999-001 | In distribution | |
| 90093-002 | In distribution | |
| 80207 | In distribution | |
| 80086 | In distribution | |
| 80150-00C | In distribution | |
| 800061 | In distribution | |
| 80110-001 | In distribution | |
| 90094-003 | In distribution | |
| 80202-001 | In distribution | |
| 80101-001 | In distribution | |
| 90097-004 | In distribution | |
| 80300-001 | In distribution | |
| 80151-001 | In distribution | |
| 80303-001 | In distribution | |
| 80031-004 | In distribution | |
| 80099 | In distribution | |
| 800060 | In distribution | |
| 90094-001 | In distribution | |
| 80800-005 | In distribution | |
| 90093-003 | In distribution | |
| 80093 | In distribution | |
| 80801-001 | In distribution | |
| 90097-003 | In distribution | |
| 80092 | In distribution | |
| 80088 | In distribution | |
| 80800-004 | In distribution | |
| 80102-001 | In distribution | |
| 80089 | In distribution | |
| 80206-001 | In distribution | |
| 80100-001 | In distribution | |
| 80091 | In distribution | |
| 80104-001 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| 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 |
| 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.