Not Cleared Direct

DEN230007 - LightStrike+ (MXSUV1-SL and MXSUV1-FT) (FDA 510(k) Clearance)

Class II General Hospital device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN230007 · Xenex Disinfection Services, Inc. · General Hospital
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Sep 2023
Decision
212d
Days
Class 2
Risk

DEN230007 is an FDA 510(k) submission (not cleared) for the LightStrike+ (MXSUV1-SL and MXSUV1-FT). Classified as Whole Room Microbial Reduction Device (product code QXJ), Class II - Special Controls.

Submitted by Xenex Disinfection Services, Inc. (San Antonio, US). The FDA issued a Not Cleared (DENG) decision on September 1, 2023 after a review of 212 days.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6510 - the FDA general hospital device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the General Hospital review framework.

View all Xenex Disinfection Services, Inc. devices

Submission Details

510(k) Number DEN230007 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received February 01, 2023
Decision Date September 01, 2023
Days to Decision 212 days
Submission Type Direct
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
84d slower than avg
Panel avg: 128d · This submission: 212d
Pathway characteristics

Device Classification

Product Code QXJ Whole Room Microbial Reduction Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6510
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.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.