FDA clearances and approvals, off-label use, scope-of-practice rules, and how to read a 510(k) summary without trusting the marketing wrapper.
Merz announced FDA clearance on 11 August 2026 for Ultherapy PRIME for knee skin laxity. What the IFU covers, how it differs from a surgical lift, and who it will not…
Accure and AviClear both use 1726 nm to target oil glands. How FDA dates, treat-to-temperature vs treat-to-fluence, sessions, anesthesia, a 2024 recall, and cost…
HArmonyCa is a hybrid HA plus CaHA filler with CE Mark and a 2026 Canadian launch. It is not FDA-approved. How to read MAUDE noise, the China Phase 3 trial, and what…
Skinvive by Juvéderm gained a US neck-lines indication on 11 June 2026 (P110033/S099). What the PMA actually covers, which trial counts, duration, cost, and what still…
FDA added bemotrizinol to the OTC sunscreen monograph in June 2026. What GRASE up to 6 percent means, when US products can actually appear, and how this changes the…
FaceTite is a cleared RF-assisted lipolysis cannula; Morpheus8 is RF microneedling. Different FDA codes, different downtime, shared burn risk, and neither replaces a…
No energy device is FDA-approved for vaginal rejuvenation. What the 2018 FDA warning covers, what sham-controlled trials found, and what is approved.
Frequent straightener users had 2.55 times the uterine cancer rate in the Sister Study. Here is what that means in absolute terms, and why FDA still has not banned…
IPL is not a laser. This evidence-led breakdown covers the FDA distinction, hair-removal vs skin-rejuvenation fit, skin-of-color safety, and how to choose.
'FDA Registered' is not 'FDA Cleared.' A buyer's framework to verify aesthetic-device claims — cleared, approved, registered, CE, country-authorized — and where DJ…