OrthoPulse 2.0E (OPi2E-100)

FDA 510(k)EUDAMED

Class II (US FDA 510(k))

510(k) K230905

Identifiers

510(k) Number: K230905 FDA 510(k)
FDA Product Code: PLH FDA 510(k)

Classification

Device Class: Class II FDA 510(k)
Legislation / Framework: 21 CFR Part 872.5470 FDA 510(k)
Regulation Number: 872.5470 FDA 510(k)
Advisory Committee: Dental FDA 510(k)
FDA Decision: SESE Substantially Equivalent FDA 510(k)

The OrthoPulse 2.0E (OPi2E-100) is an Orthodontic LED Accessory, designed to deliver controlled light energy for orthodontic treatment applications. This device is classified as a Class II medical device under FDA regulations and is intended for use in dental orthodontics, providing a non-invasive method to assist in tooth movement and alignment.

Supplied as a reusable device, the OrthoPulse 2.0E (OPi2E-100) is intended for use in clinical dental settings. It is authorized under FDA 510(k) clearance (K230905) and complies with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). The device operates within the parameters of regulation number 872.5470 and is manufactured by Biolux Technology GmbH, based in Absdorf, Austria.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (2 countries)

Regulatory Authorizations

European Union Active

MDD

European Union Active

MDR

United States Active

FDA_510K

Source	Region	Type	Cert / Approval No.	Class	Status
EUDAMED	European Union	MDD	—	Class II	Active
EUDAMED	European Union	MDR	—	Class II	Active
FDA 510(k)	United States	FDA_510K	K230905	Class II	Active

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Manufacturer

Manufacturer: Biolux Technology Gmbh

Sources (2)

FDA 510(k) K230905 24 fields · synced Sep 18, 2026
EUDAMED 1 fields · synced May 19, 2026