Sofwave Medical, a company focused on energy-based, non-invasive, aesthetic devices, has obtained U.S. Food and Drug Administration (FDA) 510(k) clearance for improvement of the appearance of skin laxity on the upper arms.

Sofwave Medical是一家专注于基于能量的非侵入性美容设备的公司，已获得美国食品和药物管理局（FDA）510（k）的许可，以改善上臂皮肤松弛的外观。

The new clearance, the company said, paves the way for Sofwave to expand into additional treatment indications.

该公司表示，新的许可为Sofwave扩展到其他治疗适应症铺平了道路。

Louis Scafuri, Sofwave CEO, said, “We are pleased to receive FDA clearance for improvement of the appearance of skin laxity on the upper arms in the U.S. supported by compelling clinical study results. Lax skin on the upper arms is a prevalent issue that can impact individuals not only from a physical appearance aspect but also emotionally.

Sofwave首席执行官路易斯·斯卡福里（LouisScafuri）表示：“我们很高兴获得美国食品和药物管理局（FDA）的批准，以改善美国上臂皮肤松弛的外观，并得到令人信服的临床研究结果的支持。上臂皮肤松弛是一个普遍存在的问题，不仅会影响个人的身体外观，还会影响个人的情绪。

Whether the presence of sagging or loose skin on their upper arms is a result of aging, weight loss, genetics, or a combination of factors, the results of our upper arm laxity study provide a clear, objective clinical data set and patient outcomes further advancing our progress to become the leading provider of choice in the growing non-invasive medical aesthetic industry.

无论上臂皮肤下垂或松弛是由于衰老，体重减轻，遗传因素还是多种因素的综合作用，我们的上臂松弛研究结果提供了清晰，客观的临床数据集和患者结果，进一步推动了我们在不断发展的非侵入性医疗美容行业中成为首选供应商的进展。

We look forward to continuing to expand the use of our innovative technology to other aesthetic treatment applications throughout the body.” .

我们期待着继续将我们创新技术的应用扩展到全身其他美学治疗应用。”。。

Sofwave’s SUPERB platform introduces a viable, FDA-cleared, non-invasive alternative to improve the appearance of skin laxity on the upper arms without the associated risks and recovery time of conventional surgery, laser-based body contouring, and other minimally invasive procedures.

Sofwave的卓越平台引入了一种可行的，FDA批准的非侵入性替代方案，以改善上臂皮肤松弛的外观，而无需常规手术，基于激光的身体轮廓和其他微创手术的相关风险和恢复时间。

In the U.S., Sofwave’s tech is currently cleared for non-invasive aesthetic treatment to improve facial lines and wrinkles, lift the eyebrow, and lift lax submental (beneath the chin) and neck tissue. The Sofwave system is also cleared for short-term improvement in the appearance of cellulite and for the treatment of acne scars.

在美国，Sofwave的技术目前被批准用于非侵入性美学治疗，以改善面部线条和皱纹，抬起眉毛，抬起松弛的颏下（下巴下方）和颈部组织。Sofwave系统还可以短期改善脂肪团的外观和治疗痤疮疤痕。

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