Shenzhen Qiaochengli Technology Co., Ltd.
Product code OHT· 21 CFR 878.4810
Product code
Predicate devices
Cited as predicate
FDA 510(k) registration fields
The IPL HAIR REMOVAL Device (Model: TFDA06S-A) is an over-the-counter device indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
The IPL HAIR REMOVAL Device (Model: TFDA06S-A) is an over-the-counter device indicated for the removal of unwanted hair. The device is also indicated for the permanent reduction in hair regrowth, defined as the long-term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regime. The device is used for adults.
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