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FDA Recall & Compliance Alerts for Medspa Owners
FDA CLEAREDLED Light Therapy Mask (K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K) — Guangdong Newdermo Biotech Co., Ltd.2 weeks agoFDA CLEAREDVeineo System (00MEDRF4000TCUS 05CR45iT 06Pedal1St) — F Care Systems USA, LLC4 weeks agoFDA CLEAREDCoolSeal Generator® (CSL-200-90) — Hologic, Inc.2 weeks agoFDA CLEAREDMILAN System — Lumenis Be, Ltd.4 weeks agoFDA CLEAREDPICOSURE WORKSTATION — Cynosure, LLC2 weeks agoFDA CLEAREDCurrentBody Skin LED Multi Light Therapy Mask (MK-110D) — The Beauty Tech Group, Ltd.4 weeks agoFDA CLEAREDLED Neck Beauty Mask (ZLD-66A,ZLD-90E,ZLD-130,ZLD-180H) — Shenzhen Kaiyan Medical Equipment Co., Ltd.2 weeks agoFDA CLEAREDLumiGlam Laser System (SHE-LSP601-3) — Beijing Sano Laser S&T Development Co.,Ltd4 weeks agoFDA CLEAREDBarbed PDO Suture — Sutura Medical Technology, Inc.3 weeks agoFDA CLEAREDLipocosm Harmonic System — Lipocosm, LLC3 weeks agoFDA CLEAREDIntense Pulsed Light Therapy Device — Sanhe LEFIS Electronics Co., Ltd.3 weeks agoFDA CLEAREDERBECRYO 2 Cryosurgical Unit and Accessories — Erbe Elektromedizin GmbH3 weeks ago
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Injectables

Allergan Aesthetics Wins FDA Approval for Skinvive by Juvéderm — Neck Indication Expands Filler Portfolio

AbbVie's newest Juvéderm indication targets neck laxity and wrinkles, adding a high-margin treatment to the injectable mix.

Image: Inside MedSpa

Allergan Aesthetics has secured FDA approval for Skinvive by Juvéderm for improvement of neck appearance, marking the first Juvéderm indication specifically cleared for the neck and décolletage. The product is a smooth, cohesive gel formulation designed to address loss of elasticity and fine lines in this notoriously difficult-to-treat zone.

Neck treatment commands premium pricing—often 1.5× to 2× the per-syringe margin of cheek or lip work.

For practice owners, this is a direct revenue play. Neck treatment commands premium pricing—often 1.5× to 2× the per-syringe margin of cheek or lip work—because it requires precision, volume, and repeat sessions. Skinvive's approval gives you a branded, FDA-cleared entry point into a market previously dominated by off-label Juvéderm Ultra XC or Volbella. The indication also sits squarely in the Allē loyalty ecosystem, meaning rebate velocity and per-unit economics will track with AbbVie's broader toxin and filler bundling strategy.

Source: original report ↗

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