FDA WARNING_LETTER - Laser Therapeutics, Inc.

The FDA issued a Warning Letter to Laser Therapeutics, Inc. on March 21, 2008, for marketing its Softlaser device (also known as Beurer, Etrans, and Vitalmed) in the U.S. without required marketing clearance or approval. The FDA determined the Softlaser is a medical device based on its intended uses, which include treating conditions like acne, eczema, herpes, and pain, as stated in its "Guidelines for Use" and on the firm's website. These claims, even with disclaimers like "Non-US Conditions," establish the device's medical intent. The device is deemed adulterated under section 501(f)(1)(B) of the Act (21 U.S.C. 351(f)(1)(B)) due to the absence of an approved Premarket Approval (PMA) or Investigational Device Exemption (IDE). It is also misbranded under section 502(o) of the Act (21 U.S.C. 352(o)) for failing to submit a 510(k) premarket notification. Additionally, the firm failed to comply with 21 CFR 1010.3 by not providing an identification label with manufacturing location and date, and with 21 CFR 1002.13 for not submitting an Annual Report for July 1, 2006, through June 30, 2007. Laser Therapeutics must promptly correct these deviations and respond within fifteen working days, outlining corrective actions and preventative measures. Failure to comply could lead to regulatory actions such as seizure, injunction, civil money penalties, and impact on federal contracts.