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Omega Engineering Inc. was warned for offering the TI-120GTS infrared thermometer for sale in the United States with marketing claims that the product mitigates, prevents, treats, diagnoses, or cures COVID-19, thereby making it a medical device under FDA jurisdiction. The company violated FDA regulations by marketing and selling this device without obtaining required premarket approval (PMA), clearance, or authorization, rendering the product adulterated under the Federal Food, Drug, and Cosmetic Act. These violations were identified through FDA's review of the company's website and YouTube channel, which contained statements positioning the temperature measurement device as a tool for COVID-19 pandemic response and disease prevention.