BioPhotas, Inc. has attained ISO 13485:2003 Certification for the design, manufacture and distribution of Low-Level Light Therapy devices and announced that its Celluma PRO and Celluma LITE products have received CE Mark Certification for sales the European Union.
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, according to the company. 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 within a single product configuration.
“From the beginning of its development, we recognized the Celluma’s potential as an effective wound healing device,” Patrick Johnson, president and CEO of BioPhotas, said in a press statement. “Accordingly, much of our original clinical research has been in the area of wound healing.”
In published and peer-reviewed research conducted at the Beckman Laser Institute at the University of California, Irvine, the Celluma was shown to accelerate the rate of wound closure, according to the Johnson, who added that the company is working to make the Celluma 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. Regarding the Low-Level Light Therapy device certifications, the company pointed out that ISO 13485 is an international quality system standard for medical devices.
