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The Houva-NET Control System is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for the treatment of psoriasis and vitiligo. The Houva V with Houva -NET Control System is a therapeutic product designed for individuals who require specific Ultraviolet radiation therapy for diagnosed skin disorders.

The Houva V with Houva-NET Control System is simply the integration of the new Houva-NET Control System software, into the predicate device, the Houva III Phototherapy System with PhotoSense II™. The Houva -NET Control System software is utilized to monitor multiple phototherapy devices from a single computer, the Houva-NET Central Computer. The central computer may be used to monitor mulitiple phototherapy devices from one central location. A custom built interface board. 5PCB-040, supplied by National Biological Corporation is installed in each phototherapy device. An "off-the shelf" replacement is not possible and a replacement may only be obtained from National Biological Corporation. Schematics are located in the Device Description of this 510(k) submission, Section 11. The integration of the new Houva-NET Control System software into the predicate device, the Houva III Phototherapy System with PhotoSense II™, results in the modified system or the Houva V with Houva-NET Control System. The modification, as compared to the predicate, is limited to the replacement of the PhotoSense II Controller with the new Houva-NET Control. The Houva V with Houva-NET Control System software is designed to provide Ultraviolet A (UVA) and/or Ultraviolet B (UVB) radiation treatments in the same manner as the predicate device. The Houva-NET Control System may be retrofitted into any Houva Phototherapy Systems, constructed in the same design configuration as the predicate device. Houva III Phototherapy System with PhotoSense II™ (K041212) and utilizing identical energy source (UV Lamps) and materials of identical composition. The Houva V with Houva-NET Control System's only variation from the predicate device is that the control system hardware and software have been updated to control multiple phototherapy units. The intended use, general and specific indications for use, spectral output, mode of operation, labeling, treatment area, and general operating principals of the Houva V with Houva-NET Control System are the same as those of the predicate. Additionally, the use of control system software and interface board to manage multiple phototherapy devices have already received FDA market clearance under K110912 integrated into the Daavlin Smart Touch Multi-Machine Software.