Clinical Lasers, Inc. – FDA Warning Letter

On November 14, 2013, the FDA issued a Warning Letter to Clinical Lasers, specifically addressing Stephen Soos, President & CEO. The letter states that Clinical Lasers is marketing numerous devices, including various Sigma, Omnilase, OmniPhotonix, OmniYag, QuadWave, OmniFace, OmniSculpt, Hanya, NeXus, LumiSlim, and Q-Switched Nd, Standard Cooling IPL, Big Spot IPL lasers, and the Sigma iShape body contour & skin uplift system, without FDA clearance or approval.

These products are considered devices under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act) due to their intended use in diagnosis, cure, mitigation, treatment, prevention of disease, or affecting body structure/function. The FDA found that Clinical Lasers had not obtained marketing clearance or approval for these devices, rendering them adulterated under section 501(f)(1)(B) of the Act and misbranded under section 502(o) of the Act. The firm failed to obtain premarket approval (PMA) or an investigational device exemption (IDE), and did not provide the required 510(k) notification of intent to introduce the devices into commercial distribution.

Clinical Lasers is required to immediately cease activities resulting in the misbranding or adulteration of these devices, including commercial distribution. The firm must submit a written response