BioPhotas Receives ISO and CE Mark Certifications

BioPhotas recently announced it has attained ISO 13485:2003 certification for its design, manufacturing, and distribution of Low-Level Light Therapy devices. This certification is an international quality system standard for medical devices, and is a hallmark of achievement for 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,” says CEO and president Patrick Johnson. “We are proud that our products are made in the U.S. and that we are contributing to the local economy, building the company here in Orange County.”

Established to offer a new approach to biophotonic therapy for medical providers and consumers, BioPhotas develops and markets devices that conveniently treat a variety of pain, dermatology, and musculoskeletal conditions. The company also recently announced that its products, including the Celluma Pro and Celluma Lite have received CE Mark Certification, which allows the products to be sold in the European Union (EU) as a medical device. The Celluma has also been CE-marked as a dermal wound healing device and FDA-cleared for seven procedures, including the treatment of acne, muscle and joint pain, muscle and joint stiffness, muscle spasm, arthritis, compromised local blood circulation, and facial wrinkles. Says Johnson, “From the beginning of its development, we recognized the Celluma’s potential as an effective wound healing device,” says Johnson. “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.”  

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