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QXJ — Whole Room Microbial Reduction Device Class II

FDA Device Classification

Classification Details

Product Code
QXJ
Device Class
Class II
Regulation Number
880.6510
Submission Type
Review Panel
HO
Medical Specialty
General Hospital
Implant
No

Definition

A whole room microbial reduction device is a medical device to be used to reduce microbial load on medical device surfaces following cleaning and disinfection.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K242604preventamed technologies, inc. dba surfacide manufacturingHelios+ UV-C SystemMay 27, 2025
DEN230007xenex disinfection servicesLightStrike+ (MXSUV1-SL and MXSUV1-FT)September 1, 2023