Portable Light Source
LED Portable Light Source
11manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (2), Anhui (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Micro-Tech (Nanjing) Co., Ltd. | Nan Jing | Jiangsu | Contract manufacturer | 49 |
| Shenzhen Eyco Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 27 |
| Shenzhen Hugemed Medical Technical Development Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 22 |
| Scivita Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 19 |
| Dongguan Miqiang Technology Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 15 |
| Shenzhen Yiguangnian Innovation Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 13 |
| Anqing Changfan Medical Instrument Co., Ltd. | Anqing | Anhui | Manufacturer | 9 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Shanghai Seegen Photoelectric Technology Co., Ltd. | Shanghai | Shanghai | Manufacturer | 7 |
| Hunan Endoso Life Technology Co., Ltd. | Xiangtan | Hunan | Manufacturer | 7 |
| Shenzhen Sophway Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 3 |
Record
| Listed by | Optim LLC, United States |
|---|---|
| FDA product code | NTN |
| Device type | Led Light Source |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K091829 |
| Record published | 2016-09-19 |
| Record revised | 2021-12-22 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| F0063873L1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Led Light Source | Schölly Fiberoptic GmbH | 12 |
| Lucea LED® | Maquet Gmbh | 9 |
| Endolight | Richard Wolf Gmbh | 7 |
| ILO | ILO Electronic Gmbh | 7 |
| BR Surgical, LLC | BR Surgical LLC | 7 |
| Led Light Source | Karl Storz GmbH & Co. KG | 6 |
| Everlux Light Source | Ecleris SRL | 5 |
| eLUMA | ConMed Corporation | 5 |
| Led Light Source | Maquet Gmbh | 4 |
| Gimmi | Gimmi Gmbh | 4 |
| Comeg Medical | Sopro | 4 |
| Led Light Source | Richard Wolf Gmbh | 4 |
Showing 12 of 42. All products under Led Light Source
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K091829 | 2009-07-28 |
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.