FDA clearances and approvals, off-label use, scope-of-practice rules, and how to read a 510(k) summary without trusting the marketing wrapper.
TrenibotE is the first serotype E neurotoxin submitted for FDA approval. Onset in 8 hours, duration of 2–3 weeks, over 2,100 patients studied. April 2026 CRL addresses…
20 original PMA approvals since 1981, 1,036 total PMA records, and a recent wave of new entrants: what the FDA premarket-approval database reveals about who makes the…
66 FDA MAUDE reports for microneedling devices: Ellacor leads with 28 reports, SkinPen injuries rising in 2025, and FDA's Oct 2025 RF microneedling safety warning.
223 FDA MAUDE reports for ultrasound aesthetic devices: Ultherapy drives 72% of events, Sofwave surged in 2025, and 91% describe patient injuries including burns and fat…
2,506 aesthetic clinical trials from ClinicalTrials.gov analyzed: 361 active, 177 device trials in the pipeline, 51 late-stage studies near market. Facial aesthetics and…
304 FDA aesthetic-device recall records: breast implants account for 55% of aesthetic recalls, Allergan dominates with 13 entries, and the 2019 BIOCELL withdrawal is the…
ASPS procedural statistics: neuromodulator injections lead at 9.5M procedures, minimally invasive exceeds 90% of volume, and surgical growth centers on body contouring…
FDA MAUDE data for aesthetic energy devices: CoolSculpting PAH drives 11,257 reports, laser burns and scarring account for 3,540 injuries, and events spiked 360% from…
98,626 FAERS reports for aesthetic injectables: Botox accounts for 77% of events, Daxxify has the highest serious-event rate at 88%, and top reactions differ sharply…
Indiana signed SB 282, Iowa and Arizona introduced bills, Florida and Massachusetts proposed legislation — all requiring med spa registration, responsible practitioners,…