Zhuolu Jontelaser Manufacturing Technology Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Dermatological Diode Laser Systems 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 hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The Dermatological Diode Laser Systems 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 hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.
The proposed device, Dermatological Diode Laser Systems, is a surgical device intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI). There are 2 models included, T5 Pro and T8 Pro, which have the same intended use, mechanism of action, principle, and specifications, with differences in configuration. The main components include a handpiece for delivering the laser, a touchscreen for user interface, an emergency switch, a key switch, a connector for the handpiece, an indicator lamp, and a foot switch to activate laser emission.
Summary parsed at:2026-06-01 05:41:32 UTC
Diode Laser Therapy System
K202257 references 1 predicate/reference device
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