MICRO NEEDLING THERAPY SYSTEM

Description of Event or Problem

MARKETING OF AN UNCLEARED CLASS II DEVICE. THE MICRONEEDLING DEVICE IS MARKETED FOR AESTHETIC SKIN IMPROVEMENT [¿DIMINISH THE APPEARANCE OF FINE LINES AND WRINKLES¿, ¿HELPS FADE THE APPEARANCE OF DARK SPOTS¿, ETC.]. MICRONEEDLING DEVICES FOR AESTHETIC USE ARE CLASS II DEVICES UNDER 21 CFR 878.4430 AND REQUIRE 510(K) CLEARANCE. (B)(6). RELIANCE ON A CONTESTED CLASSIFICATION THEORY. (B)(6) MAINTAINED INTERNALLY THAT THE DEVICE IS NOT A MEDICAL DEVICE BECAUSE IT DOES NOT DELIVER THE SERUM THROUGH THE NEEDLES, BUT INSTEAD PUNCTURES THE SKIN SO THAT THE SERUM RUNS DOWN THE OUTSIDE OF THE NEEDLES AND IS ABSORBED THROUGH THE CHANNELS CREATED. THE DEVICE IS NONETHELESS INTENDED FOR AESTHETIC SKIN TREATMENT AND PENETRATES THE DERMIS. (B)(6) THIS FOR THE FDA¿S ASSESSMENT OF WHETHER THE DEVICE REQUIRES CLEARANCE AND WHETHER THE DEVICE-AND-SERUM COMBINATION CONSTITUTES A COMBINATION PRODUCT, OR THE SERUM AN UNAPPROVED NEW DRUG. TWO KNOWN SERIOUS INJURIES. (B)(6): AT LEAST ONE CUSTOMER WAS HOSPITALIZED FOLLOWING (B)(6) IN AN EARLIER FORMULATION OF THE ANTI-AGING SERUM. THE FORMULATION WAS SUBSEQUENTLY CHANGED. AT LEAST ONE CUSTOMER HAD A (B)(6) DURING APPLICATION OF THE DEVICE. (B)(6) THE UNDERLYING RECORDS FOR EITHER INCIDENT AND (B)(6). APPARENT FAILURE TO REPORT SERIOUS ADVERSE EVENTS. (B)(6) THESE EVENTS WERE NOT REPORTED TO THE FDA. IF (B)(6) IS THE RESPONSIBLE PERSON FOR THE SERUM UNDER THE MODERNIZATION OF COSMETICS REGULATION ACT OF 2022 (MOCRA), A HOSPITALIZATION IS A SERIOUS ADVERSE EVENT SUBJECT TO MANDATORY REPORTING. THE INJURY INVOLVING THE DEVICE MAY ALSO BE SUBJECT TO DEVICE REPORTING OBLIGATIONS. REQUESTED ACTION (B)(6) THE FDA TO DETERMINE WHETHER THIS DEVICE REQUIRES 510(K) CLEARANCE AND IS BEING MARKETED WITHOUT IT, WHETHER THE SERUM OR THE DEVICE-AND-SERUM COMBINATION IS PROPERLY CLASSIFIED, AND WHETHER THE COMPANY HAS MET ITS ADVERSE-EVENT REPORTING OBLIGATIONS. (B)(6).