Recall & Approval Tracker
A running timeline of FDA recalls and device clearances that touch medical aesthetics — what changed, when, and what it means for med spa owners.
4 recalls
19 clearances
last 180 days
- FDA CLEARED EasyWhip Family — Winter Innovations, Inc.
- FDA CLEARED LED Light Therapy Masks (LED Face Mask Pro FAC08NA, LED Chest Mask Pro FAC09NA) — Guangdong Newdermo Biotech Co., Ltd.
- FDA CLEARED LUTRONIC GENIUS — Cynosure Lutronic Technology Corporation
- FDA CLEARED CURASYS 2 (EMDN0003) — CG Bio Co., Ltd.
- FDA CLEARED LED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) — Guangdong Newdermo Biotech Co., Ltd.
- FDA CLEARED 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.
- FDA CLEARED PICOSURE WORKSTATION — Cynosure, LLC
- FDA CLEARED CoolSeal Generator® (CSL-200-90) — Hologic, Inc.
- FDA CLEARED LED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) — Shenzhen Kaiyan Medical Equipment Co., Ltd.
- FDA CLEARED Barbed PDO Suture — Sutura Medical Technology, Inc.
- FDA CLEARED Intense Pulsed Light Therapy Device — Sanhe LEFIS Electronics Co., Ltd.
- FDA CLEARED ERBECRYO 2 Cryosurgical Unit and Accessories — Erbe Elektromedizin GmbH
- FDA CLEARED Lipocosm Harmonic System — Lipocosm, LLC
- FDA CLEARED LumiGlam Laser System (SHE-LSP601-3) — Beijing Sano Laser S&T Development Co.,Ltd
- FDA CLEARED CurrentBody Skin LED Multi Light Therapy Mask (MK-110D) — The Beauty Tech Group, Ltd.
- FDA CLEARED MILAN System — Lumenis Be, Ltd.
- FDA CLEARED Veineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) — F Care Systems USA, LLC
- FDA CLEARED LASEmaR 1500 — Eufoton S.R.L.
- FDA CLEARED VIVA combo RF System — Starmed Co., Ltd.
- RECALL IPG Medical Corporation — Thuvera Laser Console. Software Version 2.2. Portable Thulium Fiber Laser.
- RECALL PAYLESS COMPOUNDERS, LLC — Semaglutide-Glycine-Cyanocobalamin Injectable, 2.5 mg, 5 mg, 1 MG/ML, 0.5 mL via
- RECALL HTO Nevada Inc. dba Kirkman — MAXIMUM, ZONE 1, 4% Lidocaine Cream, 1/2 oz bottles, Distributed By: Dermal Sour
- RECALL Pro Numb Tattoo Numbing Spray LLC — Pro Numb Tattoo Numbing Spray, For Sensitive Skin, 4% Lidocaine, [1FL OZ/28.4 ML
We surface entries from FDA public databases (device & drug recalls, 510(k) clearances) filtered to the medical-aesthetics space, newest first. Each post links to the official FDA record. General business information, not medical, legal, or regulatory advice — confirm details at the source.
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