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传统脱毛之《美国FDA不允许宣传激光脱毛是永久性脱毛》-永久脱毛无忧网
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传统脱毛之《美国FDA不允许宣传激光脱毛是永久性脱毛》
作者:管理员    发布于:2009-09-20 02:06:26    文字:【】【】【

      目前,国内众多的医院、美容机构宣传激光脱毛可以永久脱毛,这实际上属于夸大宣传,不符合实际。
  国际公认最权威的美国FDA(U.S Food and Drug Administration 美国食品与药物管理局)对激光脱毛效果的认证评价如下:

原文:
HAIR REMOVAL
     The popularity of laser hair removal has increasingly grown, prompting many laser manufacturers to conduct research and seek FDA clearance for their lasers for this indication. The market is growing so quickly that FDA cannot maintain an up-to-date list of all laser manufacturers whose devices have been cleared for hair removal, as this list continues to change. To learn if a specific manufacturer has received FDA clearance, you can check FDA's Website at http://www.fda.gov/cdrh/databases.html under the 510(k) database. You will need to know the manufacturer or device name of the laser. You can also call FDA's Center for Devices and Radiological Health, Consumer Staff, at 240-276-3103, fax your request to 240-276-3151 or send an e-mail to: DSMICA@cdrh.fda.gov.

     Manufacturers should be aware that receiving an FDA clearance for general permission to market their devices does not permit them to advertise the lasers for either hair removal or wrinkle treatment, even though hair removal or wrinkle treatment may be a by-product of any cleared laser procedure. Further, manufacturers may not claim that laser hair removal is either painless or permanent unless the FDA determines that there are sufficient data to demonstrate such results. Several manufacturers received FDA permission to claim, "permanent reduction," NOT "permanent removal" for their lasers. This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair.

    The specific claim granted is "intended to effect stable, long-term, or permanent reduction" through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing after a treatment regime, which may include several sessions. The number of hairs regrowing must be stable over time greater than the duration of the complete growth cycle of hair follicles, which varies from four to twelve months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treatment area.

     FDA does not make comparisons between systems or how well or safely they work compared to another company's system. FDA does not recommend one laser system over another. Lasers cleared for body hair removal are also cleared for facial hair removal.


译文:
脱毛 
      激光脱毛日益流行,促使许多激光制造厂家进行研究并请求FDA批准他们的激光设备,由于市场如此迅速增长,FDA不能保持一份最新的设备已被批准用于脱毛的全部激光生产厂家清单,因为这个清单在持续变化,要获悉某个生产厂家是否获得FDA批准,你可以查询FDA的网站,网址是http://www.fda.gov/cdrh/databases.html,在510(k)数据库内。你需要知道制造厂家或激光设备名称。你也可以致电FDA的设备及放射健康中心,消费者顾问电话240-276-3103,也可以把你的请求发传真到240-276-3151或发电子邮件到DSMICA@cdrh.fda.gov。 
    
      制造厂家应当知道,得到FDA常规许可批准在市场上销售他们的设备,并不允许他们为激光设备脱毛或除皱做广告宣传,即使脱毛或除皱或许是一些允许的激光治疗过程的附属效果。而且,制造厂家不允许宣称激光脱毛是无痛的或永久性的,除非FDA确定有足够的数据资料证明这样的效果。一些生产厂家得到FDA许可,可以对他们的激光设备宣称“永久性减少”,而非“永久性脱除”。这表明,尽管使用这些设备进行激光治疗可以永久性减少身体毛发总数,但并不能获得全部毛发的永久性脱除效果。这个明确的宣称承认的是,通过选择性的目标命中毛囊里的黑色素“以期达到稳定的、长期的或永久性的减少”。永久性毛发减少的明确定义是,在一个可能包含几个周期的治疗过程结束后,长期的、稳定的减少毛发的再生数量。在远超过毛囊完整的生长周期的时间里,毛发再生数量必须是稳定的。毛囊的生长周期,依据身体部位从4-12个月不等。永久性毛发减少并不必然意指治疗区域内的所有毛发的脱除。

      FDA没有对不同公司的设备疗效或安全性做比较,FDA没有推荐过哪家的激光设备更好。被准许用于身体脱毛的激光设备也可以用于面部脱毛。

                                  

                                                                                          (翻译:永久脱毛无忧网)

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