FDA 510（K）清理激光器件：男性和女性脱发的疗效或安全？
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  • FDA 510（K）提交的主要机制引入医疗器械市场。
  • Submission has to demonstrate “substantial equivalency”. Many submissions require efficacy data from well controlled clinical studies
  • HairMax submission contained results of large clinical study proving efficacy
  • Submission process is rigorous leading to clearance which requires adherence to strict manufacturing and quality controls.
  • HairMax雷射是唯一FDA批准的激光销售供家庭使用的脱发。
 
The 510(k) submission is the primary mechanism by which medical devices are accepted to the market in the USA.  The FDA requires data to back equivalence claims, descriptive data and performance data to support this type of submission.

有一种普遍的误解，FDA清除激光和医疗设备，只能证明安全的基础上对营销。这种假设是不正确的，在任何情况下，也有分析进行审查临床数据，以证实新设备的医疗报销。

一个510K提交给FDA的目的是证明设备是“实质等同”谓词设备（已被FDA批准的1976年或之前上市）的。提交的材料进行比较和对比的主语和谓语设备，解释为什么他们之间的任何分歧应该可以接受。虽然人类的数据并不需要为所有的510（k），在许多情况下，良好对照的临床研究疗效数据，特别是为新的适应症的要求。根据与FDA的官员，“许多的510（k）提交的包含或需要临床数据显示实质等同”。
 

This is especially true for a new indication such as “promotion of hair growth” with lasers. 

The HairMax LaserComb was subject to this more stringent requirement and the submission of a large clinical study complying with all Good Clinical Practices in support of the efficacy of the device, led to the clearance to market the HairMax LaserComb by the FDA in 2007. 		 alt

 
There have been allegations that the 510(k) process for clearing new medical devices might be ‘cursory’.  In a letter to the N.Y. Times newspaper in November 2008, the Director of the Center for Devices and Radiological Health, FDA responded to this allegation as follows:
“……….under the congressionally established 510(k) process, the FDA often reviews laboratory and clinical data to substantiate the medical claims for a new device, based on the product’s nature and potential risk.
The data are then reviewed by experts within, and sometimes outside, the FDA.  The 510(k) process is an important tool for ensuring that devices entering the market do not raise new questions regarding safety or effectiveness”
In conclusion, the 510(k) submission process is a rigorous one that leads to clearance to market a device, but also requires adherence to strict manufacturing and quality controls. 
 
The HairMax LaserComb is the only Laser Phototherapy Device to be given clearance to market by the FDA for the regrowth of hair in males and females with certain classes of androgenetic alopecia. *
 
 
Customer Satisfaction is of Primary Importance
      alt Clinically Proven to Promote Hair Growth*
      alt Greater than 90% User Satisfaction Reported
      alt Patented and Manufactured in the USA
      alt ISO Quality Assured
      alt Proud Members of the Better Business Bureau
 
*间，HairMax高级7，力士9，和专业的12个型号表示治疗雄激素性脱发，促进头发生长男性有诺伍德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。