Tag Archives: certification

Modulight launches the world’s first multi indication CE and ETL certified medical laser

Tampere, January 28, 2015 – Modulight, Inc., a leading biomedical laser manufacturer announced today ML7710 laser platform launch and certification. Unlike other lasers in the industry Modulight ML7710 has been certified and supports a wide range of indications and configurations. Medical CE and ETL marking are valid for all multi-channel (1–8 outputs) laser configurations between 400–2000nm and up to 15W vs. typical application and wavelength specific support. ML7710 supports directly several laser based treatment modalities, like photodynamic therapy (PDT), laser surgery, photo disinfection, and photo coagulation. This saves Continue reading →

Modulight launches the world’s first multi indication CE and ETL certified medical laser

[twitter-tracking-code][twitter-tracking-code] Tampere, January 28, 2015 – Modulight, Inc., a leading biomedical laser manufacturer announced today ML7710 laser platform launch and certification. Unlike other lasers in the industry Modulight ML7710 has been certified and supports a wide range of indications and configurations. Medical CE and ETL marking are valid for all multi-channel (1–8 outputs) laser configurations between 400–2000nm and up to 15W vs. typical application and wavelength specific support. ML7710 supports directly several laser based treatment modalities, like photodynamic therapy (PDT), laser surgery, photo disinfection, and photo coagulation. This Continue reading →

Modulight launches the world’s first multi indication CE and ETL certified medical laser

Tampere, January 28, 2015 – Modulight, Inc., a leading biomedical laser manufacturer announced today ML7710 laser platform launch and certification. Unlike other lasers in the industry Modulight ML7710 has been certified and supports a wide range of indications and configurations. Medical CE and ETL marking are valid for all multi-channel (1–8 outputs) laser configurations between 400–2000nm and up to 15W vs. typical application and wavelength specific support. ML7710 supports directly several laser based treatment modalities, like photodynamic therapy (PDT), laser surgery, photo disinfection, and photo coagulation. This saves Continue reading →

Modulight ML7710-PDT laser platform CB testing completed

Tampere, Finland, September 09, 2014 – Modulight, Inc., an ISO13485 certified laser manufacturer based in Tampere, Finland and San Jose CA, announced today a landmark in medical laser technology. For the first time medical companies can purchase a multi-wavelength turnkey laser system with all design and hardware documentation ready for CE certification or FDA approval through PMA or 510(k) process. The CB certified laser system is also offered as a private label turnkey solution with a possibility for customized treatment protocols. ML7710-PDT product platform has been certified against Continue reading →

Modulight receives a contract for manufacturing CE certified medical laser systems for cancer therapy

Tampere, Finland Apr 17th 2012 – Modulight, Inc., an ISO13485:2003 certified laser manufacturer based in Tampere, Finland and San Jose, CA, announced today that it has successfully designed, integrated and CE certified an OEM medical laser system for PCI Biotech® in Oslo, Norway, for a novel cancer therapy process. PCI Biotech® has developed a unique and patented photochemical drug delivery technology, called PCI (PhotoChemical Internalisation), for use in cancer therapy and other diseases. For this purpose, Modulight delivered a CE certified 7-channel medical laser system solution Continue reading →

Modulight receives ISO 13485:2003 certification for medical laser manufacturing

Tampere, Finland, Oct 6th 2011 – Modulight, Inc. based in Tampere, Finland and San Jose, CA, announced the company has received ISO 13485:2003 certification from Det Norske Veritas (DNV). ISO 13485 is an internationally recognized quality standard which states the requirements of the Quality Management System (QMS) for the design and manufacture of medical devices. The new registration comes as an addition to ISO 9001:2008 and ISO 14001:2004 certifications received by Modulight in 2002 and 2004, respectively. It assures that the company has the fundamental Continue reading →

Modulight gets ISO14001 certification

Tampere, Finland, July 2nd, 2003 – Modulight, Inc., a manufacturer of high- performance optical semiconductor components, today announced that it has successfully certified its ISO14001 environmental management system. “Environmental management system is fully integrated in the quality management system and it works very well. Environmental aspects have been identified and relevant programs developed for the significant ones. General awareness on environmental issues and related corporate responsibilities is high.” says Ms. Elina Selin, lead auditor from BVQI which continues as Modulight’s audit partner. “We have built the Continue reading →

Modulight receives ISO 9001:2000 certification

Tampere, February 28, 2002 – Modulight, Inc. has received ISO 9001:2000 certification from Bureau Veritas Quality International (BVQI). The ISO 9001 registration has been adopted as a worldwide standard for quality, assuring that companies fulfilling its requirements have a fundamental quality management system in place. ISO 9001 registration is recognized as a true sign of quality-oriented business in the global market place. Modulight’s President & CEO, Dr. Petteri Uusimaa, stated: “We are very satisfied that BVQI audits confirm our own and 2nd party experience on the Continue reading →