Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd
Product code GEX· 21 CFR 878.4810
Product code
Cited as predicate
FDA 510(k) registration fields
The Cheveux Diode Laser System is indicated for: - Hair Removal - Permanent hair reduction - Treatment of benign vascular lesions - Treatment of benign pigmented lesions - Treatment of Leg Veins - Treatment for pseudofolliculitis barbae The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin.
The Cheveux Diode Laser System is indicated for: Hair Removal Permanent hair reduction Treatment of benign vascular lesions Treatment of benign pigmented lesions Treatment of Leg Veins Treatment for pseudofolliculitis barbae The Cheveux Laser System is intended for use on all skin types (Fitzpatrick Skin types I-VI) including tanned Skin.
The 810nm Diode Laser System consists of a console that houses the power supply, control electronics and user interface and a diode laser handpiece. The device is activated by means of a footswitch and a handswitch. The Laser System is designed for use in a clinic, which shall be a clean, dry and well-ventilated room with a door.
Summary parsed at:2026-06-01 05:54:48 UTC
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K183122 references 1 predicate/reference device
No later 510(k)s cite this device yet
Other submissions will appear here when they list K183122 as a predicate
