Manufacturer
Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd810nm Diode Laser System
Shanghai Wonderful Opto-Electrics Tech.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
- K183122
- Device name
- 810nm Diode Laser System
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2018-11-09
- Decision date
- 2019-08-25
- Submission type
- Traditional
- Technology type
- Diode(AI inferred)
- Clinical applications
- Hair removalVascular treatmentPigment treatment
- Primary application
- Hair removal
- Classification source
- AI classified
Indications for Use
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.
Intended Use
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.
Device Description
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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Cited as predicate
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