FDA Slaps Warning on Eclipse Aesthetics' Micropen Personal Dermabrasion Device
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 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.”