# DEN230007: LightStrike+ (MXSUV1-SL and MXSUV1-FT)

- Pathway: De Novo (Direct)
- Applicant: Xenex Disinfection Services, Inc.
- Decided: Sep 1, 2023 after 212 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
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Most influential descendants
- K242604: Helios+ UV-C System (2025), 0 descendants of its own

## Indications for use
The Xenex LightStrike™+ is a pulsed, broad-spectrum, high-intensity, germicidal UV 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. LightStrike+ 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/DEN230007
Methodology: https://510kreport.com/methodology