FDA clearances and approvals, off-label use, scope-of-practice rules, and how to read a 510(k) summary without trusting the marketing wrapper.
Identify whether an unopened toxin vial requires refrigeration, allows room temperature, or is unknown under current US labeling for Botox, Xeomin, and Daxxify.
FDA authorizes microneedling pens for scars and wrinkles, but not to deliver PRP, vitamins, drugs, or fillers. How to verify your appointment's device, substance, and…
Mark one fictional fat-dissolving offer as labeled KYBELLA for adult submental fat, extra-submental use of that approved drug, or an unapproved Aqualyx, Lipo Lab, or…
Identify whether a hyaluronidase vial is Hylenex recombinant, Vitrase ovine, Amphadase bovine, or compounded, and check whether filler dissolution appears on its FDA…
How to identify whether the CoolSculpting cup on your machine is an FDA Event 90331 recalled parallel-plate applicator, an Elite model, or an unnamed cup.
When clinics market PDO threads for lifting, what does the 510(k) really clear? Compare soft-tissue approximation, mid-face suspension indications, and unapproved claims.
When a clinic moves remaining laser sessions to a substitute machine after downtime, use this patient question worksheet to verify device identity, consent, and package…
Reconstruct a published cosmetic responder rate by scale, rater, baseline, n/N, timepoint, and missing follow-up before comparing aesthetic trial claims.
Juvelook is a Korean PDLLA-HA injectable with MFDS and CE marks, not a US filler PMA. A MoCRA serum, PLLA filler language, and undereye FDA claims are not approval.
Renuva is a US HCT/P adipose matrix, not an FDA-approved dermal filler. Clinic FDA-approved-filler claims, a January 2021 list, and Renuvion 510(k) hits are not a PMA.