meddevicedb.com FDA Device Reference

LightStrike+ (MXSUV1-SL and MXSUV1-FT)

DEN230007 Class II Direct
Decision Date
2023-09-01
Sponsor / Applicant
Xenex Disinfection Services, Inc.

Technical Specification

510(k) Submission ID DEN230007
Product Code QXJ
Medical Specialty / Panel General Hospital
Regulation Citation 21 CFR 880.6510
Decision Date 2023-09-01
Clearance Pathway Direct

Official Documentation

No FDA summary/statement PDF is linked for this clearance in the current dataset. Consult the product code and regulation citation above to locate predicate documentation.

Clearance Summary

LightStrike+ (MXSUV1-SL and MXSUV1-FT) received FDA 510(k) clearance under submission number DEN230007, sponsored by Xenex Disinfection Services, Inc.. The device was reviewed via the Direct premarket notification pathway and assigned to the General Hospital review panel. The statutory decision date of record is 2023-09-01.

Classification & Regulation

This clearance is catalogued under FDA product code QXJ and 21 CFR 880.6510, within the General Hospital review panel as a Class II device.