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This MDR certification marks a substantive step forward for the entire field of photodynamic therapy, confirming our approach meets the highest regulatory bar for medical devices in Europe. This achievement provides crucial, standardized assurance regarding the quality and compliance of our technology. Koite Health is positioned as a preeminent leader in navigating the complex transition to MDR compliance within the photodynamic space.
Koite Health CEO Peter Radqvist
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New Multicenter Randomized Trial: Daily Home-Applied Dual-Light Therapy Improves Key Periodontitis Outcomes When Added to Standard Care

The new LumoNorth2022 multicenter trial provides additional evidence for the recently published large HOPE-CP study. Together, the two randomized clinical trials suggest that daily at-home Lumoral® dual-light therapy supports professional periodontal care and improves gum health between dental visits.A new multicenter, randomized, controlled clinical trial published in the Journal of Periodontology reports that daily at-home use of Lumoral® dual-light antibacterial therapy, when added to standard periodontal maintenance care, produced significantly greater improvements in gum inflammation,

Koite Health Secures EU MDR Quality Management System Certification for Lumoral Phototherapy Devices

Stockholm, 12 November 2025 – Koite Health Oy today announced that it has received the EU Quality Management System Certificate under the European Medical Device Regulation. The certificate covers the company’s Class IIa phototherapy equipment for the treatment and prevention of oral diseases caused or exacerbated by dental plaque – including its Lumoral and Lumoral Junior devices and their accessories. This certification follows a rigorous evaluation process involving a thorough audit of Koite Health’s quality management system and an in-depth technical documentation assessment of the

Antibacterial Treatment: A Game-Changer in Periodontitis Management

The latest results from Europe’s largest randomized periodontitis study (HOPE-CP) confirm that integrating antibacterial Lumoral therapy into standard dental care delivers remarkable improvements in oral health and professional treatment outcomes.Six-month findings reveal that Lumoral users experienced significantly better oral hygiene, reduced gum inflammation, and fewer deep periodontal pockets. These compelling results reinforce Lumoral as a powerful adjunct therapy, helping dentists achieve superior clinical outcomes in managing periodontitis. By harnessing advanced antibacterial

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