Helios+ UV-C System
K-Number: K242604 · 2025-05-27
Decision Date2025-05-27
Product CodeQXJ
Advisory CommitteeHO
DecisionSubstantially Equivalent
Device Summary
Helios+ UV-C System is a medical device manufactured by Preventamed Technologies, Inc. Dba Surfacide Manufacturing. It received FDA 510(k) clearance on 2025-05-27 under approval number K242604. The device is classified under product code QXJ. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Helios+ UV-C System?
Helios+ UV-C System is a medical device that received FDA 510(k) clearance on 2025-05-27. It is manufactured by Preventamed Technologies, Inc. Dba Surfacide Manufacturing. The 510(k) number is K242604.
When was Helios+ UV-C System approved by the FDA?
Helios+ UV-C System received FDA 510(k) clearance on 2025-05-27, under approval number K242604.
What company makes Helios+ UV-C System?
Helios+ UV-C System is manufactured by Preventamed Technologies, Inc. Dba Surfacide Manufacturing.
What is the FDA product code for Helios+ UV-C System?
The FDA product code for Helios+ UV-C System is QXJ.
Related Devices (Code: QXJ)
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.