510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K230905Substantially Equivalent

OrthoPulse 2.0E (OPi2E-100)

Biolux Technology GmbH, Absdorf, AT / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K230905 is the FDA 510(k) clearance record for OrthoPulse 2.0E (OPi2E-100), a class II device, cleared for Biolux Technology GmbH on under FDA product code PLH (Orthodontic Led Accessory). FDA's definition for product code PLH reads: "Intended for use during orthodontic treatment. It is used in conjunction with brackets and wires or aligners and helps facilitate minor anterior tooth movement". FDA records list one 510(k) clearance for Biolux Technology GmbH. As of , FDA records show no recalls naming K230905.

Clearance record

Decision date
Received
(70 days to decision)
Product code
PLH Orthodontic Led Accessory
Regulation
21 CFR 872.5470
Device class
Class II
Review panel
Dental
Applicant
Biolux Technology GmbH Neubaugasse 31, Absdorf, AT
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PLH

Trailing 12 months

FDA records hold no clearances under product code PLH in the trailing twelve months.

FDA records show no clearances under product code PLH in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PLH, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260