FDA clearances and approvals, off-label use, scope-of-practice rules, and how to read a 510(k) summary without trusting the marketing wrapper.
Nine original PMA applications, 400 total PMA records, and the 2024 entry of Motiva: what the FDA premarket-approval database reveals about who makes the breast implants…
384 FDA clearances for at-home IPL, LED, and RF devices show a category exploding to 71 in 2025, with Shenzhen maker Ulike now dominating and real injury reports…
347,618 FDA MAUDE reports on silicone and saline breast implants: rupture and capsular contracture dominate, BIA-ALCL reporting spiked with the 2019 Allergan recall, and…
An evidence map of cellulite from 62 clinical trials and the FDA record: Cellfina subcision lasts longest, RESONIC clears dimples in one session, and the Qwo injectable…
11,280 FDA MAUDE reports under cryolipolysis code OOK: 95.1% describe paradoxical adipose hyperplasia (PAH), reporting surged a thousand-fold from 2019 to 2023, and…
Full FAERS analysis of 1,968 deoxycholic-acid (Kybella) reports: nerve-injury terms lead, off-label and 'drug ineffective' rank high, and a paradoxical fat-growth signal…
526 FDA MAUDE reports on liposuction devices show injuries and malfunctions split nearly even, VASER ultrasound systems dominate, and thermal burns are the signature…
Regenerative aesthetics mapped from 77 trials and the FDA record: PRP leads the research, exosomes and polynucleotides have no U.S. approval, and unapproved stem-cell…
Only about 10 registered trials back thread lifts, and most are non-randomized. Large case series show a real lift lasting roughly 6 to 12 months — not the years…
22,242 FDA MAUDE reports for dermal fillers (product code LMH): the Juvéderm family leads at 55%, HA fillers drive 72% of all reports, and a 2025 surge pushed annual…