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HairMax激光生发梳FDA批准用于男性和女性:在脱发的治疗里程碑和促进头发生长*
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- HairMax雷射FDA批准为女性*在2011年进行营销
- 在2011年,4间,HairMax模型FDA批准用于市场营销
- HairMax雷射原本是FDA批准用于市场营销,男性在2007年*
- Indicated for “Treatment of Hair Loss and Promotion of Hair Growth” *
- An ideal drug free treatment option
- All data submitted as part of 510(k) rigorously scrutinized and reviewed
- Clearance set up stringent requirements and standards in manufacturing and quality control
- HairMax can be used alone or with other medications
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间,HairMax已经获得了营销的4个里程碑FDA的间隙。 2011年6月间,HairMax收到对头发的生长,女性型脱发FDA批准*在2011年8月间,HairMax双12模式获得FDA批准。 2011年4月,收到了HairMax雷射三款新车型的遗传性脱发和头发生长促进男性治疗FDA清关* 2007年1月,在HairMax激光生发梳®成为第一个也是唯一的医疗激光设备接收的男性遗传性脱发的治疗FDA批准上市*
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HairMax LaserComb's FDA 501(k) Clearance as a medical device for marketing was based primarily on proof of EFFICACY .
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手牵手同列克星敦国际的坚定承诺,让客户满意,产品的制造商追求昂贵的临床试验,以帮助安心客户的头脑,同时巩固作为男性和女性脱发治疗的HairMax雷射效果。 。
To put it simply, we know about the countless products on the market that promise to re-grow hair, but end up having little or no effectiveness. And apart from draining your pocket, they do nothing to improve your hair loss problem.
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现在已经有5 HairMax激光生发梳的FDA的间隙,这意味着所有的营销data submitted was subject to intense scrutiny and review方能营销清除。当公司收到此关,都有严格的规则,高标准落实到位,包括制造和质量控制的各个方面。该HairMax激光生发梳是唯一的激光光疗设备,已通过美国FDA审查和营销为在男性和女性的遗传性脱发的治疗四次清除*.我们的临床数据是提交给FDA,严格对所有510(K)提交审查。
It is these milestone clearances that allows us to ensure the effectiveness of the HairMax. |
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HairMax: A Truly Unique Non-Drug Hair Loss Treatment Option
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The FDA marketing clearance of the HairMax LaserComb® has significant implications for the Hair Loss Treatment industry. Currently, there are only two other FDA approved hair loss treatments available, but with the addition of the HairMax, there is now a viable drug free, topical free alternative to these methods. 该HairMax雷射,具有良好的安全记录,没有严重的副作用。它是一次性购买,没有持续的成本。
请注意,虽然HairMax雷射工程以及一个独立的治疗,它可以使用与其他认可您选择的疗法结合它。请记住,战斗脱发是一场艰苦的战役和FDA批准的HairMax雷射*市场现在让你更近了一步赢得脱发的战斗。 |
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HairMax Hair Loss Treatment Studies and the FDA Clearance Process
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2010年,列克星敦国际提交其6个月,多中心控制设备为女性型脱发治疗的临床试验的结果。从试验的数据表明,100%的参加者,所有25-60,经验丰富的头发生长。此外,头发的厚度和丰满的主题评估了显着的控制设备HairMax雷射。无严重副作用的报道。
In June 2011 the FDA granted marketing Clearance for the HairMax for the treatment of female pattern hair loss.* In August 2011, the FDA granted marketing Clearance for the HairMax Dual 12 device and for and additional 3 new HairMax models, the HairMax Professional 12, HairMax Lux 9 and HairMax Advanced 7.
经过广泛的研究和随机临床研究多年,列克星敦国际提交其6个月,多中心临床试验在2006年控制安慰剂的结果。从试验中收集的数据表明,93%的参加者,年龄30-60所有男性,有一个头发生长在医学上显着增加。无严重副作用的报道。
所有的临床试验提供确凿的证据表明,HairMax雷射是有效的,对遗传性脱发在男性和女性的治疗是安全的。该HairMax雷射是为那些希望避免药物和/或topicals使用那些可行的治疗选择。
关键临床与HairMax激光生发梳而导致原FDA批准上市进行研究的结果发表在2009年5月的临床药物研究问题。文章题为HairMax激光生发梳在治疗男性雄性秃光疗设备,药品的索引作为Clin投资2009年:29(5):在如MEDLINE,EMBASE /医学文摘生物医学数据库最283-292等。研究还表明,在没有任何的试验参与者任何严重的不良影响。
To learn more about our Clinical Studies - Click Here
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*The HairMax Advanced 7, Lux 9, and the Professional 12 models are indicated to treat Androgenetic Alopecia, and promote hair growth in 男性有诺伍德V和汉密尔顿IIA的分类女性路德维希(Savin)的I - 4,II - 1,II - 2,或脱发,谁都有菲茨帕特里克皮肤类型I至IV的正面图案。 |
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| Customer Satisfaction is of Primary Importance |
Clinically Proven to Promote Hair Growth* |
Greater than 90% User Satisfaction Reported |
Patented and Manufactured in the USA |
ISO Quality Assured |
Proud Members of the Better Business Bureau |
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