FDA warns cosmetic device maker over lack of approval, demands halt to sales

The FDA this week released a warning letter it sent to cosmetic device maker A-1 Engineering over a lack of FDA clearance to market its devices, requesting the company halt sales of the devices.

The federal watchdog also referenced a number of quality control issues with the company’s manufacturing facilities in Rancho Cucamonga, Calif.

A-1 Engineering makes the Neurotris SX-Series machines and Neurotris PICO Toner microcurrent facial and body sculpting systems, which the company claims are “a non-surgical approach to improve and return a youthful appearance,” according to its site.

The FDA said the company registered the devices originally as “electric therapeutic massagers,” which are exempt from the need for premarket approval, but the company has marketed them outside that indication.

“Generic devices of this type (electric therapeutic massagers) are intended for medical purposes, such as to relieve minor muscle aches and pains. However, your firm is marketing the devices for different intended uses, including, but not limited to, wrinkle reduction, facial lifting, neck tightening, increased ATP production, increased collagen and elastin, improved circulation, skin tightening, cellulite reduction, enhancement of biological processes, hydrolysis of triglycerides, improving sun damaged skin and skin pigmentation, iontophoresis, fat reduction, and muscle building and toning,” the FDA wrote in its warning letter.

The FDA quoted the company’s brochures, which advertise the devices as being able to far exceed the purpose they were registered under, referencing a grocery list of claims outside the devices original marketed indication.

The federal watchdog requested that A-1 “immediately cease activities that result in the misbranding or adulteration of the Neurotris SX-Series Machines and PICO Toner,” including halting all commercial distribution of the devices.

In addition, the FDA knocked the company on 7 different points from its inspection of A-1’s facilities.

Included in the list were: failure to maintain device master records; failure to maintain device history records; failure to establish procedures to ensure sold devices conform to requirements; failure to evaluate potential suppliers based on evaluations; failure to maintain complaint files; failure to establish cleaning and maintenance schedules and a failure to establish quality system procedures.

A-1 was asked to submit an application for premarket approval and the FDA requested the company respond within 15 days to the notification.

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