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美國FDA不允許宣稱激光脫毛是永久性脫毛
 
 
 
    目前,國內大量的醫院、美容院宣傳激光脫毛可以永久脫毛,這實際上屬于夸大宣傳。冰點脫毛,實際上就是激光脫毛。國內對激光脫毛還起了許多不同的商業名詞。

  國際公認最權威的美國FDA(U.S Food and Drug Administration 美國食品與藥物管理局)對激光脫毛效果的認證評價如下:

原文地址:

//www.fda.gov/Radiation-EmittingProducts/RadiationEmittingProductsandProcedures/
SurgicalandTherapeutic/ucm142607.htm#8

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 //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: [email protected]

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.


譯文:

脫毛
激光脫毛日益流行,促使許多激光制造廠家進行研究并請求FDA批準他們的激光設備,由于市場如此迅速增長,FDA不能保持一份最新的設備已被批準用于脫毛的全部激光生產廠家清單,因為這個清單在持續變化,要獲悉某個生產廠家是否獲得FDA批準,你可以查詢FDA的網站,網址是//www.fda.gov/cdrh/databases.html,在510(k)數據庫內。你需要知道制造廠家或激光設備名稱。你也可以致電FDA的設備及放射健康中心,消費者顧問電話240-276-3103,也可以把你的請求發傳真到240-276-3151或發電子郵件到[email protected]。 制造廠家應當知道,得到FDA常規許可批準在市場上銷售他們的設備,并不允許他們為激光設備脫毛或除皺做廣告宣傳,即使脫毛或除皺或許是一些允許的激光治療過程的附屬效果。而且,制造廠家不允許宣稱激光脫毛是無痛的或永久性的,除非FDA確定有足夠的數據資料證明這樣的效果。一些生產廠家得到FDA許可,可以對他們的激光設備宣稱“永久性減少”,而非“永久性脫除”。這表明,盡管使用這些設備進行激光治療可以永久性減少身體毛發總數,但并不能獲得全部毛發的永久性脫除效果。這個明確的宣稱承認的是,通過選擇性的目標命中毛囊里的黑色素“以期達到穩定的、長期的或永久性的減少”。永久性毛發減少的明確定義是,在一個可能包含幾個周期的治療過程結束后,長期的、穩定的減少毛發的再生數量。在遠超過毛囊完整的生長周期的時間里,毛發再生數量必須是穩定的。毛囊的生長周期,依據身體部位從4-12個月不等。永久性毛發減少并不必然意指治療區域內的所有毛發的脫除。

FDA沒有對不同公司的設備療效或安全性做比較,FDA沒有推薦過哪家的激光設備更好。

被準許用于身體脫毛的激光設備也可以用于面部脫毛。

                                      ?。ǚ搿穹羧擻讕猛衙彝?br>

 

     
  相關專題:激光脫毛實際效果因人而異,因部位而異  
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