EXCI308 by Aerolase
Exci308® by Aerolase This medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. Excimer light source, wavelength 308nm, optical…
Exci308® by Aerolase This medical device is intended to be used for the treatment of psoriasis, vitiligo, atopic dermatitis, and leukoderma. Excimer light source, wavelength 308nm, optical power 2500 mW.
Who Else Makes It
Concentrated in Guangdong (3), Shanghai (2), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Global Fabtech Wheel Chair (Shanghai) Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 15 |
| Xuzhou Yongkang Electronic Science Technology Co., Ltd. | Xuzhou | Jiangsu | Contract manufacturer | 13 |
| Xuzhou Kernel Medical Equipment Co Ltd | Xuzhou | Jiangsu | Contract manufacturer | 7 |
| APK Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 6 |
| Shenzhen GSD Tech Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 5 |
| Shenzhen Peninsula Medical Group | Shenzhen | Guangdong | Manufacturer | 4 |
| Chongqing Peninsula Medical Technology Co., Ltd. | Chongqing | Chongqing | Repacker / relabeller | 2 |
| Shanghai Sigma High-Tech Co., Ltd. | Shanghai | Shanghai | Manufacturer | 1 |
Record
| Listed by | Clarteis, France |
|---|---|
| FDA product code | FTC |
| Device type | Light, Ultraviolet, Dermatological |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4630 |
| Establishment | Manufacturer |
| 510(k) | K191086 |
| Record published | 2022-06-13 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| Storage | Storage environment temperature -20 to 70 °C; Storage environment humidity up to 95 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EIPL-100 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Daavlin | Daavlin Distributing Co., THE | 559 |
| National Biological Corporation | National Biological Corp. | 68 |
| Kernel | Xuzhou Kernel Medical Equipment Co Ltd | 31 |
| Solarc/SolRx E-Series | Solarc Systems Inc. | 16 |
| UVBioTek | Medtek Lighting Corporation | 12 |
| Solarc/SolRx 100-Series | Solarc Systems Inc. | 7 |
| Solarc/SolRx 1000-Series | Solarc Systems Inc. | 7 |
| Solarc/SolRx 500-Series | Solarc Systems Inc. | 7 |
| Boston Aesthetics | Shenzhen Peninsula Medical Group | 4 |
| Panosol 6-3D | Daavlin Distributing Co., THE | 4 |
| Panosol 6 | Daavlin Distributing Co., THE | 4 |
| Panosol 6 | National Biological Corp. | 4 |
Showing 12 of 43. All products under Light, Ultraviolet, Dermatological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K191086 | 2019-12-11 |
| K171702 | 2017-10-13 |
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.