{ "name": "FDA Recalls & 510(k) Clearances — Medical Aesthetics", "description": "FDA device/drug recalls and 510(k) clearances relevant to medical spas and aesthetic practices, last ~180 days.", "source": "Inside MedSpa", "homepage": "https://insidemedspa.com/fda-tracker/", "license": "Free to use with attribution and a link back to insidemedspa.com.", "attribution": "Data via Inside MedSpa — https://insidemedspa.com/fda-tracker/", "updated": "2026-08-24T16:11:31.508Z", "count": 23, "events": [ { "type": "clearance", "title": "EasyWhip Family — Winter Innovations, Inc.", "date": "2026-07-01", "slug": "easywhip-family-winter-innovations-inc-20260701", "url": "https://insidemedspa.com/fda-tracker/easywhip-family-winter-innovations-inc-20260701/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261021" }, { "type": "clearance", "title": "LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) — Guangdong Newdermo Biotech Co., Ltd.", "date": "2026-06-29", "slug": "led-light-therapy-masks-led-face-mask-pro-fac08na-led-chest-mask-20260629", "url": "https://insidemedspa.com/fda-tracker/led-light-therapy-masks-led-face-mask-pro-fac08na-led-chest-mask-20260629/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261052" }, { "type": "clearance", "title": "LUTRONIC GENIUS — Cynosure Lutronic Technology Corporation", "date": "2026-06-29", "slug": "lutronic-genius-cynosure-lutronic-technology-corporation-20260629", "url": "https://insidemedspa.com/fda-tracker/lutronic-genius-cynosure-lutronic-technology-corporation-20260629/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253484" }, { "type": "clearance", "title": "CURASYS 2 (EMDN0003) — CG Bio Co., Ltd.", "date": "2026-06-23", "slug": "curasys-2-emdn0003-cg-bio-co-ltd-20260623", "url": "https://insidemedspa.com/fda-tracker/curasys-2-emdn0003-cg-bio-co-ltd-20260623/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253199" }, { "type": "clearance", "title": "LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) — Guangdong Newdermo Biotech Co., Ltd.", "date": "2026-06-18", "slug": "led-light-therapy-mask-k9c-tk-k9c-k-k9p-yk-k9p-k-fm-03bk-fm-09k-20260618", "url": "https://insidemedspa.com/fda-tracker/led-light-therapy-mask-k9c-tk-k9c-k-k9p-yk-k9p-k-fm-03bk-fm-09k-20260618/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260946" }, { "type": "clearance", "title": "Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8) — Micro-Energy Medical Technology Co., Ltd.", "date": "2026-06-18", "slug": "hemolase-fiber-hemo-r-0-40-2-5-hemo-r-0-60-2-5-hemo-r-0-40-1-8-h-20260618", "url": "https://insidemedspa.com/fda-tracker/hemolase-fiber-hemo-r-0-40-2-5-hemo-r-0-60-2-5-hemo-r-0-40-1-8-h-20260618/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261701" }, { "type": "clearance", "title": "PICOSURE WORKSTATION — Cynosure, LLC", "date": "2026-06-17", "slug": "picosure-workstation-cynosure-llc-20260617", "url": "https://insidemedspa.com/fda-tracker/picosure-workstation-cynosure-llc-20260617/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261570" }, { "type": "clearance", "title": "CoolSeal Generator® (CSL-200-90) — Hologic, Inc.", "date": "2026-06-17", "slug": "coolseal-generator-csl-200-90-hologic-inc-20260617", "url": "https://insidemedspa.com/fda-tracker/coolseal-generator-csl-200-90-hologic-inc-20260617/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253634" }, { "type": "clearance", "title": "LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) — Shenzhen Kaiyan Medical Equipment Co., Ltd.", "date": "2026-06-16", "slug": "led-neck-beauty-mask-zld-66a-zld-90e-zld-130-zld-180h-shenzhen-k-20260616", "url": "https://insidemedspa.com/fda-tracker/led-neck-beauty-mask-zld-66a-zld-90e-zld-130-zld-180h-shenzhen-k-20260616/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K254025" }, { "type": "clearance", "title": "Barbed PDO Suture — Sutura Medical Technology, Inc.", "date": "2026-06-12", "slug": "barbed-pdo-suture-sutura-medical-technology-inc-20260612", "url": "https://insidemedspa.com/fda-tracker/barbed-pdo-suture-sutura-medical-technology-inc-20260612/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252171" }, { "type": "clearance", "title": "Intense Pulsed Light Therapy Device — Sanhe LEFIS Electronics Co., Ltd.", "date": "2026-06-12", "slug": "intense-pulsed-light-therapy-device-sanhe-lefis-electronics-co-l-20260612", "url": "https://insidemedspa.com/fda-tracker/intense-pulsed-light-therapy-device-sanhe-lefis-electronics-co-l-20260612/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261204" }, { "type": "clearance", "title": "ERBECRYO 2 Cryosurgical Unit and Accessories — Erbe Elektromedizin GmbH", "date": "2026-06-09", "slug": "erbecryo-2-cryosurgical-unit-and-accessories-erbe-elektromedizin-20260609", "url": "https://insidemedspa.com/fda-tracker/erbecryo-2-cryosurgical-unit-and-accessories-erbe-elektromedizin-20260609/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K261806" }, { "type": "clearance", "title": "Lipocosm Harmonic System — Lipocosm, LLC", "date": "2026-06-08", "slug": "lipocosm-harmonic-system-lipocosm-llc-20260608", "url": "https://insidemedspa.com/fda-tracker/lipocosm-harmonic-system-lipocosm-llc-20260608/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K251944" }, { "type": "clearance", "title": "LumiGlam Laser System (SHE-LSP601-3) — Beijing Sano Laser S&T Development Co.,Ltd", "date": "2026-06-04", "slug": "lumiglam-laser-system-she-lsp601-3-beijing-sano-laser-s-and-t-de-20260604", "url": "https://insidemedspa.com/fda-tracker/lumiglam-laser-system-she-lsp601-3-beijing-sano-laser-s-and-t-de-20260604/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260690" }, { "type": "clearance", "title": "CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) — The Beauty Tech Group, Ltd.", "date": "2026-06-03", "slug": "currentbody-skin-led-multi-light-therapy-mask-mk-110d-the-beauty-20260603", "url": "https://insidemedspa.com/fda-tracker/currentbody-skin-led-multi-light-therapy-mask-mk-110d-the-beauty-20260603/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260715" }, { "type": "clearance", "title": "MILAN System — Lumenis Be, Ltd.", "date": "2026-06-02", "slug": "milan-system-lumenis-be-ltd-20260602", "url": "https://insidemedspa.com/fda-tracker/milan-system-lumenis-be-ltd-20260602/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253803" }, { "type": "clearance", "title": "Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) — F Care Systems USA, LLC", "date": "2026-06-02", "slug": "veineo-system-00medrf4000tcus-05cr45it-06pedal1st-f-care-systems-20260602", "url": "https://insidemedspa.com/fda-tracker/veineo-system-00medrf4000tcus-05cr45it-06pedal1st-f-care-systems-20260602/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253918" }, { "type": "clearance", "title": "LASEmaR 1500 — Eufoton S.R.L.", "date": "2026-05-29", "slug": "lasemar-1500-eufoton-s-r-l-20260529", "url": "https://insidemedspa.com/fda-tracker/lasemar-1500-eufoton-s-r-l-20260529/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K260489" }, { "type": "clearance", "title": "VIVA combo RF System — Starmed Co., Ltd.", "date": "2026-05-26", "slug": "viva-combo-rf-system-starmed-co-ltd-20260526", "url": "https://insidemedspa.com/fda-tracker/viva-combo-rf-system-starmed-co-ltd-20260526/", "fda_source": "https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K252833" }, { "type": "recall", "title": "IPG Medical Corporation — Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.", "date": "2026-05-05", "slug": "ipg-medical-corporation-thuvera-laser-console-software-version-2-20260505", "url": "https://insidemedspa.com/fda-tracker/ipg-medical-corporation-thuvera-laser-console-software-version-2-20260505/", "fda_source": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts" }, { "type": "recall", "title": "PAYLESS COMPOUNDERS, LLC — Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL via", "date": "2026-03-06", "slug": "payless-compounders-llc-semaglutide-glycine-cyanocobalamin-injec-20260306", "url": "https://insidemedspa.com/fda-tracker/payless-compounders-llc-semaglutide-glycine-cyanocobalamin-injec-20260306/", "fda_source": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts" }, { "type": "recall", "title": "HTO Nevada Inc. dba Kirkman — MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Sour", "date": "2026-02-18", "slug": "hto-nevada-inc-dba-kirkman-maximum-zone-1-4-lidocaine-cream-1-2-20260218", "url": "https://insidemedspa.com/fda-tracker/hto-nevada-inc-dba-kirkman-maximum-zone-1-4-lidocaine-cream-1-2-20260218/", "fda_source": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts" }, { "type": "recall", "title": "Pro Numb Tattoo Numbing Spray LLC — Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML", "date": "2026-02-02", "slug": "pro-numb-tattoo-numbing-spray-llc-pro-numb-tattoo-numbing-spray-20260202", "url": "https://insidemedspa.com/fda-tracker/pro-numb-tattoo-numbing-spray-llc-pro-numb-tattoo-numbing-spray-20260202/", "fda_source": "https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts" } ] }