The FDA issued a warning letter to Eclipse Aesthetics because it had concerns that the firm’s MicroPen Elite dermabrasion device has the potential to damage vessels and nerves.
Eclipse Aesthetics failed to submit a premarket approval application or an investigational device exemption for the device before marketing it, the May 28 warning letter said.
The agency noted that dermabrasion devices that don’t require premarket approval have abrasion substrates, which are brushes and burrs that abrade and remove layers of skin. However, the Eclipse MicroPen is intended to achieve its clinical effect by penetrating the skin.
The Eclipse MicroPen Elite, which is classified as a Class I device for microdermabrasion and treatment of scars, consists of microneedles and uses a “different fundamental scientific technology than a device classified under 21 CFR 878.4820,” the letter says.
Noting that the device was not exempt from premarket notification due to the penetration depths of the needles and speeds of the device, the agency said that safe ranges for needle lengths, penetration depths, and speeds of the device are not known.
“Therefore, FDA has safety concerns regarding the potential for the needles to damage vessels and nerves,” the letter concludes.
The FDA deemed the device misbranded and adulterated and requested that the firm stop selling the device immediately.
Read the warning letter here: www.fdanews.com/05-18-16-EclipseWarningLetter.pdf. — Joya Patel