Photonvue Optical Head
Optical head of the PhotonVue system
3manufacturers in China registered for this device type
1catalogue number
1510(k) clearance
Who Else Makes It
Concentrated in Guangdong (1), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Qingdao O-MEC Medical Technology Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 6 |
| Guangdong Optomedic Technologies, Inc. | Foshan | Guangdong | Manufacturer | 7 |
| Wuxi Hisky Medical Technologies Co., Ltd. | Wuxi | Jiangsu | Manufacturer | 4 |
Record
| Listed by | Fluoptics SAS, France |
|---|---|
| FDA product code | OWN |
| Device type | Confocal Optical Imaging |
| Device class | Class 2 |
| Regulation | 21 CFR 876.1500 |
| Establishment | Complaint-file establishment, Manufacturer |
| 510(k) | K132475 |
| Record published | 2018-01-19 |
| Record revised | 2022-02-01 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Distribution end date | 2018-08-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| PVUECOH-1.0 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| VS3-IR | Visionsense, Ltd. | 22 |
| Confocal Microprobe Imaging System | Wuxi Hisky Medical Technologies Co., Ltd. | 16 |
| Confocal Optical Imaging | Karl Storz GmbH & Co. KG | 13 |
| Hopkins | Karl Storz GmbH & Co. KG | 4 |
| AIM (Advanced Imaging Modality) | Stryker GmbH | 4 |
| VS3-NE | Visionsense, Ltd. | 3 |
| Open Field Fluorescence Imaging Head | Guangdong Optomedic Technologies, Inc. | 3 |
| Cellvizio® 100 series (488nm) | Mauna KEA Technologies | 3 |
| Photonvue | Fluoptics SAS | 2 |
| VS3 Iridium | Visionsense, Ltd. | 2 |
| SafeLight | Stryker GmbH | 2 |
| 1588 AIM | Stryker GmbH | 2 |
Showing 12 of 74. All products under Confocal Optical Imaging
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K132475 | 2014-05-07 |
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.