DEN230007 is an FDA 510(k) submission for the LightStrike+ (MXSUV1-SL and MXSUV1-FT). This device is classified as a Whole Room Microbial Reduction Device (Class II - Special Controls, product code QXJ).
Submitted by Xenex Disinfection Services, Inc. (San Antonio, US). The FDA issued a Not Cleared (DENG) decision on September 1, 2023.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.6510. 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..
| 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 | - |
| Product Code | QXJ - Whole Room Microbial Reduction Device |
| Device Class | Class II - 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. |