Solarc/SolRx 100-Series
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 1-BULB UVB-Narrowband Handheld Device. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema). For use with 220 to…
Ultraviolet Phototherapy Lamp Unit, Solarc/SolRx 100-Series 1-BULB UVB-Narrowband Handheld Device. Indications for Use: Psoriasis, Vitiligo, Atopic Dermatitis (Eczema). For use with 220 to 240 volt supply power.
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 | Solarc Systems Inc., Canada |
|---|---|
| FDA product code | FTC |
| Device type | Light, Ultraviolet, Dermatological |
| Device class | Class 2 |
| Regulation | 21 CFR 878.4630 |
| Establishment | Manufacturer |
| 510(k) | K061589 |
| Record published | 2016-09-17 |
| Record revised | 2025-10-09 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 110UVB-NB-230V | In distribution | |
| ARM-100 | In distribution | |
| 110UVB | In distribution | |
| 120UVB-NB-230V | In distribution | |
| 110UVB-NB | In distribution | |
| 120UVB-NB | In distribution | |
| 120UVB | 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 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 |
| Panosol 6-3D | National Biological Corp. | 4 |
Showing 12 of 43. All products under Light, Ultraviolet, Dermatological
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K103204 | 2011-04-27 |
| K061589 | 2006-08-04 |
| K031800 | 2003-09-10 |
| K935572 | 1994-03-07 |
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.