510(k) K242604
K242604 is an FDA 510(k) premarket notification submitted by Preventamed Technologies, Inc. Dba Surfacide Manufacturing for the device "Helios+ UV-C System". The FDA issued a decision of Substantially Equivalent on May 27, 2025. 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
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 2025
- Date Received
- August 30, 2024
- Clearance Type
- Traditional
- 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.