Product code GEX· 21 CFR 878.4810
Product code
Predicate devices
Cited as predicate
FDA 510(k) registration fields
The MediDiode is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hair regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The MediDiode is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin. Permanent hair reduction is defined as the long-term, stable reduction in the number of hair regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
Summary parsed at:2026-06-01 05:26:27 UTC
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