Regulation Number: 21 CFR 890.5500, Product Code: ILY & NHN
Phototherapy is an application of light applied to human tissue to launch a new realm of science. In the last several years, we have been part of many 510(k) for low level light laser therapy devices cleared by the FDA / CDRH.
Light energy is known to stimulate beneficial effects on
human tissue. Regardless of the terminology, such as:
infrared light, Phototherapy, Photo medicine, LLLT low level
light therapy, laser therapy, light therapy, LED therapy, photo
medicine, photon therapy, or regardless of whether the
emission is coherent or incoherent light and its infrared
component is known to stimulate beneficial effects on human
tissue.
Compliance Consultants has designed, consulted on design, and submitted many, many 510(k)s for low level light therapy devices to the FDA and consulted with low level light therapy companies regarding their marketing.
Medical science has employed almost all forms of the electromagnetic spectrum to treat ailments in the human body. Each decade, a host of new treatments emerge and are embodied into conventional therapy. Light is designed by nature to provide many both known and unknown benefits to human health.
Compliance Consultants has designed, consulted on design, and submitted many, many 510(k)s for low level light therapy devices to the FDA and consulted with low level light therapy companies regarding their marketing.
Medical science has employed almost all forms of the electromagnetic spectrum to treat ailments in the human body. Each decade, a host of new treatments emerge and are embodied into conventional therapy. Light is designed by nature to provide many both known and unknown benefits to human health.
