MINNEAPOLIS (CN) - Sybaritic, an international distributor of "aesthetic equipment," is importing and selling dangerous medical devices, federal prosecutors say. Prosecutors say Sybaritic makes unauthorized claims for its laser products, alters its medical and spa devices without approval and has not reported equipment that causes serious injuries.
Sybaritic designs and sells devices for laser surgery and dermatology. Its devices include Dermalife, NannoLight MP50, SkinClear SRVH, LaserPeel, Trimatrixx, SkinBella, Dermasonic and SlimLine, according to the complaint.
Sybaritic sells its devices to treat or prevent disease, and "affect the structure or function" of a person's body, but never sough approval for this, prosecutors say. It uses foreign companies to manufacture some of its equipment.
The FDA claims that Sybaritic has not sought clearance for many of its products, including its microdermabrasion system, SkinBella.
The company also made unapproved changes to its pulsed light and laser system, NannoLight MP50, and several other devices, which may compromise the devices' "safety or effectiveness," according to the complaint.
Prosecutors say Sybaritic makes unauthorized claims for its products, and neglected to report devices that have caused serious injuries.
The government says Sybaritic has been cited for similar violations since its first inspection in 2004. The FDA has issued several warning letters to Sybaritic for its promotional brochures, which advertised its products as medical devices, though it did not have clearance to make such claims, according to the FDA.
Sybaritic executives Steven Daffer, Anthony Daffer and product manager Ronald Berglund have been notified of the numerous violations, but have not taken steps to correct them, officials say.
The FDA seeks an injunction and costs.
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