Ivylaser (Beijing) Technology Co.,Ltd
Product code OHT· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
IVYLASER Handhold Hair Removal Machine is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. IVYLASER is also intended for permanent hair reduction defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
IVYLASER Handhold Hair Removal Machine is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. IVYLASER is also intended for permanent hair reduction defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The proposed device is an over-the-counter device intended for adjunctive use with shaving for hair removal sustained with periodic treatments. It is also intended for permanent hair reduction. Three models (iyoung mini-P, iyoung mini-GY, iyoung mini-GN) are included in IVYLASER Handhold Hair Removal Machine series products, and they have the same intended purposes and working theories. The main components list of proposed device includes a device host for removing hair from the body and a power adapter that provides stable current and voltage.
Summary parsed at:2026-06-11 04:37:53 UTC
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K230025 references 1 predicate/reference device
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