The FDA recently released a warning letter it sent to Eclipse Aesthetics, claiming the company lacks appropriate regulatory clearance for its Eclipse Micropen Elite, which it describes as a “dermal micro-needling device” used for skincare applications.
The letter came after an FDA inspection in August last year uncovered that the Eclipse MicroPen Elite did not have appropriate regulatory clearance to be used as advertised, saying its classification as a powered dermabrasion advice was incorrect.
The Federal watchdog said the product labeling of the device describes that the system “allows for controlled collagen induction therapy by creating microinjuries in the skin which trigger new collagen synthesis.”
The cordless Eclipse MicroPen device, as described on the company’s website, uses a disposable cartridge tip consisting of 12 needle points to penetrate the skin vertically through the use of a high-speed motor. The company states the device comes with disposable cartridge tips that are surgical grade.
Speed on the device is variable and the information on the website advises that a lubricant be applied to the face pre-use.
The company claims the microinjuries created in the device aid in the production of collagen and elastin, and that the skin’s repair process results in a thicker epidermis with a softer appearance of wrinkles. It also claims microinjuries from the device create micro-channels that allow topical gels, creams and serums to be absorbed more effectively.
The federal watchdog said it determined the device consists “of a stamp of needles that is controlled by a motor to make multiple controlled-depth penetrations perpendicularly into the skin.”
The safe range of needle lengths, penetration depths and speeds of the device are unknown, the FDA said. This raised concerns over the possibility of needles damaging vessels and nerves, the agency added.
Eclipse labeled the device as Class I FDA registered, designed for dermabrasion and the treatment of scars, exempt from premarket notification through classification as a powered dermabrasion device.
Devices labeled as powered dermabrasion devices generally use abrasion substrates, such as brushes, rasps and burs intended to remove layers of the skin through force, the FDA said.
Because the Eclipse device penetrates the skin, it is not exempt as a powered dermabrasion device, the agency writes in its warning letter.
The FDA requested the company cease marketing the device. The company’s website currently lists that the device is “Currently not being sold in the USA,” but is available internationally.