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FDA 510(k)

OrthoPulse 2.0E (OPi2E-100)

K-Number: K230905 · 2023-06-09

ApplicantBiolux Technology GmbH
Decision Date2023-06-09
Product CodePLH
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OrthoPulse 2.0E (OPi2E-100) is the device name listed in this FDA 510(k) record. The listed applicant is Biolux Technology GmbH. It received FDA 510(k) clearance on 2023-06-09 under 510(k) number K230905. The device is classified under product code PLH. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OrthoPulse 2.0E (OPi2E-100)?

OrthoPulse 2.0E (OPi2E-100) is a medical device that received FDA 510(k) clearance on 2023-06-09. The listed applicant is Biolux Technology GmbH. The 510(k) number is K230905.

When did OrthoPulse 2.0E (OPi2E-100) receive FDA 510(k) clearance?

OrthoPulse 2.0E (OPi2E-100) received FDA 510(k) clearance on 2023-06-09, under 510(k) number K230905.

Who is the listed applicant for OrthoPulse 2.0E (OPi2E-100)?

The FDA 510(k) record lists Biolux Technology GmbH as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OrthoPulse 2.0E (OPi2E-100)?

The FDA product code for OrthoPulse 2.0E (OPi2E-100) is PLH.

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.

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