K242604
- 510(k) number
- K242604
- Device name
- Helios+ UV-C System
- Applicant
- Preventamed Technologies, Inc. Dba Surfacide Manufacturing WI · US
- Product code
- QXJ — Whole Room Microbial Reduction Device
- Decision date
- 2025-05-27
- Date received
- 2024-08-30
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Advisory committee
- General Hospital
510(k) Summary (official FDA PDF): K242604.pdf
Official FDA record: K242604
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.