OrthoPulse 2.0E (OPi2E-100)— 510(k) K230905

Name: FDA 510(k) clearance K230905
Creator: U.S. Food and Drug Administration
Published: 2023-06-09

Substantially Equivalent

Biolux Technology GmbH

FDA 510(k) clearance K230905 for OrthoPulse 2.0E (OPi2E-100), Substantially Equivalent on 2023-06-09. Applicant: Biolux Technology GmbH. Device class: 2.

Clearance details

Applicant: Biolux Technology GmbH
Product code: Code PLH
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2023-03-31
Decision date: 2023-06-09
Decision: Substantially Equivalent
Clearance type: Special
Location: Absdorf, AT

Download summary PDF View on FDA.gov ↗

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