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 the device name listed in this FDA 510(k) record. The listed applicant is Preventamed Technologies, Inc. Dba Surfacide Manufacturing. It received FDA 510(k) clearance on 2025-05-27 under 510(k) 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. The listed applicant is Preventamed Technologies, Inc. Dba Surfacide Manufacturing. The 510(k) number is K242604.
When did Helios+ UV-C System receive FDA 510(k) clearance?
Helios+ UV-C System received FDA 510(k) clearance on 2025-05-27, under 510(k) number K242604.
Who is the listed applicant for Helios+ UV-C System?
The FDA 510(k) record lists Preventamed Technologies, Inc. Dba Surfacide Manufacturing as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Helios+ UV-C System?
The FDA product code for Helios+ UV-C System is 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.