ExSys 308
ExSys 308 is an ultraviolet light system for treating psoriasis and vitiligo on intact skin. A xenon-chloride excimer lamp in the applicator delivers monochromatic UVB light at 308 ± 4 nm.…
ExSys 308 is an ultraviolet light system for treating psoriasis and vitiligo on intact skin. A xenon-chloride excimer lamp in the applicator delivers monochromatic UVB light at 308 ± 4 nm.
The base unit provides touchscreen controls, a key switch, emergency stop and speaker. The applicator uses integrated air cooling, and treatment tips set the distance from the skin.
Listed Item
Excimer light 308 nm system
Treatment Interface
The treatment area is 50 by 35 mm. A hand switch or optional foot switch activates delivery, with dosage and exposure-time controls. The reusable applicator is disinfected between patients, and the spacer is the patient-contacting component.
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 | Gme German Medical Engineering GmbH, Germany |
|---|---|
| FDA product code | FTC |
| Device type | Light, Ultraviolet, Dermatological |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4630 |
| 510(k) | K150752 |
| Record published | 2018-04-16 |
| Record revised | 2019-02-07 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | manufacturing date, serial number |
| Storage | Storage environment temperature -10 to 60 °C; Handling environment temperature 18 to 30 °C; Storage environment humidity 0 to 99 % RH; Handling environment humidity 0 to 89 % RH |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1000 | 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 |
|---|---|
| K150752 | 2015-07-31 |
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.