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Sofwave Medical, Ltd.

FDA 510(k) & PMA Approved Devices — 12 products

Total Devices12
Categories2
Latest FDA decision2025-07-02
TypeNumberDevice NameCodeDateActions
510(k) K251746 Pure ImpactNGX2025-07-02 View
510(k) K250146 SofWave SystemNGX2025-04-18 View
510(k) K241685 SofWave SystemNGX2024-08-07 View
510(k) K240687 SofWave SystemOHV2024-05-30 View
510(k) K233104 SofWave SystemOHV2023-12-22 View
510(k) K232455 SofWave SystemOHV2023-12-14 View
510(k) K231537 SofWave SystemOHV2023-08-28 View
510(k) K230820 SofWave SystemOHV2023-04-18 View
510(k) K230019 SofWave SystemOHV2023-03-14 View
510(k) K223237 SofWave SystemOHV2022-12-16 View
510(k) K211483 SofWave SystemOHV2021-11-15 View
510(k) K191421 Sofacia SystemOHV2019-09-09 View

Related Clinical Trials

NCT07685821In Vivo Study to Evaluate Tissue Remodeling Via Fibroblast Stimulation Following a Single SofWave TreatmentACTIVE_NOT_RECRUITINGNCT07685834Evaluation of Facial and Neck Skin Laxity With SofWave Treatment in Adults Initiating Tirzepatide for Weight LossACTIVE_NOT_RECRUITINGNCT07723664Evaluation of SofWave Sofware-Guided Energy Delivery for Lower Face and Neck RejuvenationNOT_YET_RECRUITING
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