Helios+ UV-C System

The Helios+ UV-C System is a portable, germicidal ultraviolet light device that emits 253.7 nm wavelength UV-C light to reduce microbial contamination on non-porous, non-critical medical device surfaces in unoccupied rooms. It is used in operating rooms, hospital rooms, and clinical settings as an adjunct to manual cleaning and disinfection, and is available over-the-counter (OTC).

Helios+ uses continuous 253.7 nm UV-C light and can be deployed in multiple configurations with 1-3 emitters, whereas the predicate uses pulsed broad-spectrum UV light with a single emitter. Helios+ is remotely operated via a Bluetooth-connected control tablet with up to 3 wireless safety sensors, while the predicate uses an on-device touchpad and a single tethered motion detection cone. Both achieve identical 2-log microbial reduction performance on target organisms.

IEC 62471 (Photobiological Safety of Lamps and Lamp Systems), IEC 61010-1 (electrical safety), IEC 61326-1 (electromagnetic compatibility), ISO 4582, ASTM D256-10, ASTM A370-22 (materials durability), and 21 CFR 801.415 (ozone limits). FDA guidance on device software and cybersecurity was also applied.

Both devices are whole-room microbial reduction systems with identical intended use, regulatory classification, and demonstrated 2-log microbial reduction performance on the same target organisms. Although Helios+ differs in operational controls (tablet vs. touchpad), emitter configuration (1-3 vs. single), wavelength delivery method (continuous vs. pulsed), and safety sensor design (wireless vs. tethered), these technological differences do not raise different safety or effectiveness questions because the non-clinical testing shows equivalent or superior performance, proper safety controls are maintained, and the fundamental mechanism and microbial reduction outcomes remain substantially the same.