Recently, Ostar Beauty Sci-Tech Co. Ltd., based in Beijing, China, has received a Warning Letter from the US Food and Drug Administration (FDA) for marketing several products in the United States without the necessary marketing clearance or approval. This action is part of a broader initiative by the FDA to address manufacturers of devices and over-the-counter (OTC) products that fail to comply with regulatory requirements.
It is reported that Ostar Beauty Sci-Tech Co. Ltd. was founded in 2009 with a registered capital of 1 million yuan. The company is engaged in the research and development, production, and marketing of medical beauty and personal beauty devices. Its main products include Derma Rollers, Derma Pens, Needle Cartridges, and LED Masks.
According to the FDA, the products marketed by Ostar Beauty Sci-Tech Co. Ltd. in violation of the Federal Food, Drug, and Cosmetic Act include 3 Levels Injection Insulin Gun Hyaluronic Acid Skin Injection Needle Free Pen, Derma Pens, LED Masks. There are three Personal Care Devices including Super Effective 650nm Laser Hair Growth Helmet Cap, Home Cryolipolysis Fat Freezer Weight Loss Body Shape CryoPad, and Electroportation Mesotherapy Needle-Free Injection Beauty Machine.
Under the Federal Food, Drug, and Cosmetic Act, these products are classified as devices because they are intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease, or are intended to affect the structure or any function of the body. As such, they require FDA marketing clearance or approval prior to being marketed in the US.
