Helios+ UV-C System— 510(k) K242604

Name: FDA 510(k) clearance K242604
Creator: U.S. Food and Drug Administration
Published: 2025-05-27

Substantially Equivalent

Preventamed Technologies, Inc. Dba Surfacide Manufacturing

FDA 510(k) clearance K242604 for Helios+ UV-C System, Substantially Equivalent on 2025-05-27. Applicant: Preventamed Technologies, Inc. Dba Surfacide Manufacturing. Device class: 2.

Clearance details

Applicant: Preventamed Technologies, Inc. Dba Surfacide Manufacturing
Product code: Code QXJ
Device class: Class 2
Regulation: 21 CFR 880.6510
Advisory panel: General Hospital
Date received: 2024-08-30
Decision date: 2025-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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