BioPhotas attained ISO 13485:2003 Certification for the design, manufacturing and distribution of low-level light therapy devices. ISO 13485 is an international quality system standard for medical devices. Attaining such a certification is the hallmark of a global medical device manufacturer.
“Receiving ISO certification is a major milestone in the company’s evolution and serves to distinguish us from other manufacturers of light energy devices, who do not hold themselves to such high standards. We are proud that our products are 'made in the USA' and that we are contributing to the local economy, building the company here in Orange County," said Patrick Johnson, president and CEO of BioPhotas.
In relation, the company's Celluma PRO and LITE models both received CE Mark Certification, allowing for the models to be sold in the European Union as medical devices. In addition to marketing the Celluma for sale in the EU for all of its current FDA clearances, the Celluma has also been CE-marked as a Dermal Wound Healing device.
“From the beginning of its development, we recognized the Celluma’s potential as an effective wound healing device. Accordingly, much of our original clinical research has been in the area of wound healing. In published and peer-reviewed research conducted at the prestigious Beckman Laser Institute at the University of California, Irvine, the Celluma was shown to dramatically accelerate the rate of wound closure. Our intention is for the Celluma to be the first LED panel device to be FDA-cleared for a wound healing indication-for-use," added Johnson.