BILISOFT PHOTOTHERAPY SYSTEM— 510(k) K053568

Substantially Equivalent

Lumitex, Inc.

FDA 510(k) clearance K053568 for BILISOFT PHOTOTHERAPY SYSTEM, Substantially Equivalent on 2006-04-17. Applicant: Lumitex, Inc.. Device class: 2.

Clearance details

Applicant: Lumitex, Inc.
Product code: Code LBI
Device class: Class 2
Regulation: 21 CFR 880.5700
Advisory panel: General Hospital
Date received: 2005-12-22
Decision date: 2006-04-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Strongsville, OH, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.