Wednesday, June 15, 2016
BioPhotas, Inc. today announced the Company has attained ISO 13485:2003 Certification for the design, manufacture 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.
Commenting on the certification, Patrick Johnson, President & Chief Executive Officer of BioPhotas commented, "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."
In related news, BioPhotas also announced that its products, the Celluma PRO and Celluma LITE, have received CE Mark Certification, allowing the product to be sold in the European Union as a medical device. 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. The Celluma is FDA-cleared for seven separate indications-for-use, including the treatment of acne, muscle and joint pain, muscle and joint stiffness, muscle spasm, arthritis, compromised local blood circulation and facial wrinkles, all in a single product configuration.
Further commenting on the news, Mr. Johnson noted, "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." BioPhotas plans to start shipping the Celluma to EU nations early in the 3rd quarter of this year.
The Celluma PRO and LITE are now CE-marked under the European Medical Device Directive (93/42/EEC), under Annex II, Full Quality Assurance. The Celluma is Class IIa, per Annex IX, Rule 9.
Source : prnewswire.com
