FDA WARNING_LETTER - CuraeLase, Inc. - April 07, 2011

On December 9, 2011, the FDA issued a Warning Letter to CuraeLase, Inc. following an inspection from March 29 to April 7, 2011. The inspection revealed that the CL 1000 IR Laser System, cleared for temporary relief of minor muscle/joint pain and stiffness, minor arthritis pain, muscle spasm, and temporary increase in local blood circulation, was being marketed with unapproved claims. These claims included treating inflammation, edema, fibromyalgia, diabetic neuropathy, plantar fasciitis, carpal tunnel, migraine headaches, and neck, knee, and back pain, representing a major change in intended use without an approved PMA or IDE, rendering the device adulterated and misbranded.

Additionally, the device was misbranded because promotional materials falsely stated it was "FDA-approved," when it was only cleared as substantially equivalent. CuraeLase also failed to develop and implement written Medical Device Reporting (MDR) procedures, a violation of 21 CFR 803.17.

Furthermore, the CL 1000 IR Laser System, an electronic product, violated Electronic Product Radiation Control regulations by failing to submit a laser product report (21 CFR 1002.10) and annual reports (21 CFR 1002.13).

The letter also highlighted Quality System (QS) regulation concerns, including failure to establish procedures for design control (21