FDA clearances and approvals, off-label use, scope-of-practice rules, and how to read a 510(k) summary without trusting the marketing wrapper.
Vaginal laser and RF devices (MonaLisa Touch, ThermiVa) are FDA-cleared for gynecology - not for menopause GSM. The 2018 FDA warning, the evidence, and first-line…
Alopecia areata is autoimmune hair loss, not pattern baldness. Three FDA-approved JAK inhibitors (Olumiant, Litfulo, Leqselvi) finally treat severe disease — with real…
miraDry is the only FDA-cleared device that permanently destroys underarm sweat glands with microwave energy. It is not for hands or feet, and the Botox comparison is…
Vitiligo is an autoimmune loss of pigment. The 2022 FDA approval of Opzelura (ruxolitinib) made it the first repigmentation drug — used alongside NB-UVB, excimer laser,…
AviClear is a 1726 nm laser FDA-cleared to treat mild to severe inflammatory acne in all skin types. What the clearance means, what the pivotal trial showed, who it…
An analysis of 10 FDA injectable labels: every botulinum toxin carries the same boxed warning, while Kybella does not. A plain map of what the prescribing information…
Bellafill is the only FDA-approved permanent dermal filler in the US — PMMA microspheres that stay for years. What it is approved for, who is not a candidate, and why it…
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…