# K242604: Helios+ UV-C System

- Pathway: 510(k) (Traditional)
- Applicant: Preventamed Technologies, Inc. Dba Surfacide Manufacturing
- Decided: May 27, 2025 after 270 days
- Product code: QXJ (Whole Room Microbial Reduction Device)
- Device class: 2
- Regulation: 21 CFR 880.6510
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to DEN230007 (2023). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- DEN230007: LightStrike+ (MXSUV1-SL and MXSUV1-FT), Xenex Disinfection Services, Inc. (2023) Summary page 5.

## Indications for use
Helios+ is a 253.7nm wavelength, high intensity, germicidal UV-C light system intended to perform microbial reduction on non-porous, non-critical medical device surfaces, free from visual soiling, after manual cleaning and disinfection practices. Helios+ is intended for use in unoccupied operating rooms, hospital rooms and other clinical settings where non-critical medical devices are present as an adjunct to existing manual cleaning and disinfection practices. The system is for over-the-counter (OTC) use.

Source page: https://510kreport.com/device/K242604
Methodology: https://510kreport.com/methodology