510(k) DEN230007
DEN230007 is an FDA 510(k) premarket notification submitted by Xenex Disinfection Services, Inc. for the device "LightStrike+ (MXSUV1-SL and MXSUV1-FT)". The FDA issued a decision of De Novo Granted on September 1, 2023. The device falls under product code QXJ (Whole Room Microbial Reduction Device), a Class II device regulated under 21 CFR 880.6510.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- September 1, 2023
- Date Received
- February 1, 2023
- Clearance Type
- Direct
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Whole Room Microbial Reduction Device
- Device Class
- Class II
- Regulation Number
- 880.6510
- Review Panel
- HO
- Submission Type
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.