
The Company believes it is the first low-level light therapy device manufacturer to be certified to the new MDR standards
BioPhotas, Inc., the manufacturer of the award-winning Celluma SERIES of light therapy devices, announced today that the Company received certification to European Council Medical Device Regulation 2017/745 for low level light therapy devices. Over the course of the last several years, the European Medical Device Authorities have been transitioning from the Medical Device Directive (MDD) to the Medical Device Regulation (MDR). The Company believes it is the first low-level light therapy device manufacturer to be certified to the new MDR standards.
Commenting on the latest addition to the product line, BioPhotas President and Chief Executive Officer Patrick Johnson said, “It’s great to add a Hair Restoration indication-for-use to our long list of treatment clearances from the FDA. Providing a single device that treats whole body aches and pains, fine lines and wrinkles, and hair loss on the scalp is the ultimate baby-boomer anti-aging device. Now the mature individual interested in feeling and looking great, and retaining their youthful appearance, can have a device at home that meets all of their rejuvenating needs.” The Celluma RESTORE is targeted directly at the multi-billion dollar global health and wellness market, specifically, the non-invasive hair restoration segment of the medical aesthetics industry.
The Celluma RESTORE is non-toxic, non-invasive, and painless. The device is versatile, convenient, and easy-to-use in both a clinical setting or at home. Celluma’s patented, shape-taking design permits customized placement over the head to effectively deliver light energy and promote hair regrowth. Additionally, the Celluma RESTORE can be placed anywhere on the body to reduce pain and improve skin health. Measuring 16” x 8” overall with a treatment area of 14” x 6”, the Celluma RESTORE can be stored flat in a drawer for convenience and easy access.
Find more information at https://international.celluma.com
