Aurora Surgical Light Series
3 catalogue numbers from Aurora Four, listed by Skytron, LLC, United States, under Light, Surgical, Ceiling Mounted. 5 manufacturers in China are registered for this product code.
5manufacturers in China registered for this device type
3catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (2), Shandong (1), Jiangxi (1). 2 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Kaiyan Medical Equipment Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 17 |
| Beijing Aeonmed Co., Ltd. | Sanhe | Hebei | Contract manufacturer | 7 |
| Guangdong Kareway Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 16 |
| Shandong Deman Medical Equipment Group Co., Ltd. | Jining | Shandong | Manufacturer | 11 |
| Nanchang Micare Medical Equipment Co., Ltd. | Nanchang | Jiangxi | Manufacturer | 8 |
Record
| Listed by | Skytron, LLC, United States |
|---|---|
| FDA product code | FSY |
| Device type | Light, Surgical, Ceiling Mounted |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4580 |
| Establishment | Specification developer, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2016-09-19 |
| Record revised | 2024-12-11 (version 7) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment atmospheric pressure 50 to 106 KiloPascal; Handling environment humidity 10 to 85 % RH; Handling environment atmospheric pressure 50 to 106 KiloPascal; Storage environment humidity 10 to 85 % RH; Handling environment temperature -10 to 60 °C; Storage environment temperature -10 to 60 °C |
| Distribution end date | 2016-09-19 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| Aurora Four | In distribution | |
| Aurora 3 | Withdrawn | |
| Aurora LED | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HarmonyAIR | Steris Corporation | 1,344 |
| Volista | Maquet Gmbh | 677 |
| iCE Surgical Light | Amico Clinical Solutions | 599 |
| Powerled TM | Maquet Gmbh | 287 |
| Devon | Cardinal Health | 70 |
| Light, Surgical, Ceiling Mounted | Maquet Gmbh | 68 |
| Alyon | Steris Corporation | 64 |
| Medical Boom | Amico Clinical Solutions | 56 |
| Standop Volista® | Maquet Gmbh | 50 |
| Amtai | Amtai Medical Equipment, Inc. | 45 |
| Mira Minor Surgery Light | Amico Lights Corporation | 24 |
| MI Product Line | Medical Illumination International, Inc | 20 |
Showing 12 of 191. All products under Light, Surgical, Ceiling Mounted
Recalls Naming This Product
1 recall names this product by its own identifier, the UDI on its label.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| DKK DAI-Ichi Shomei Co., Ltd. | UDI-DI | 2024-07-09 | Class II | Process control | The weld on the light head frame can crack which could lead to problems such as the light head frame sagging, the plastic front face housing cracking, or the light head detaching. | 538 units |
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.