QUANTUM LIGHT THERAPY SYSTEM— 510(k) K032816

Name: FDA 510(k) clearance K032816
Creator: U.S. Food and Drug Administration
Published: 2004-03-26

Substantially Equivalent

Stargate International, Inc.

FDA 510(k) clearance K032816 for QUANTUM LIGHT THERAPY SYSTEM, Substantially Equivalent on 2004-03-26. Applicant: Stargate International, Inc.. Device class: 2.

Clearance details

Applicant: Stargate International, Inc.
Product code: Code NHN
Device class: Class 2
Regulation: 21 CFR 890.5500
Advisory panel: Physical Medicine
Date received: 2003-09-09
Decision date: 2004-03-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Parker, CO, US

Download summary PDF View on FDA.gov ↗

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