Dermatological Diode Laser Systems
Zhuolu Jontelaser Manufacturing Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K202257
- Device name
- Dermatological Diode Laser Systems
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-08-10
- Decision date
- 2021-04-23
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removal
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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
Predicate devices
1Diode Laser Therapy System
K202257 references 1 predicate/reference device
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K202257 as a predicate