Manufacturer
Shanghai Apolo Medical Technology Co., Ltd.Diode Laser Therapy Device
Shanghai Apolo Medical Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K200118
- Device name
- Diode Laser Therapy Device
- Country / Region
- China(CN)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2020-01-21
- Decision date
- 2020-04-17
- 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 Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. The treatment of benign vascular and pigmented lesions (The Laser Blanch (LB) Mode). Use on all skin types (Fitzpatrick I-VI), including tanned skin. (HR, SHR and LB Modes)
Intended Use
The Diode Laser Therapy Device is indicated for permanent reduction in hair regrowth defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen. It is suitable for all skin types (Fitzpatrick skin type I-VI), including tanned skin.
Device Description
The Diode Laser Therapy Device is designed to be used in dermatological practice for stable, long term hair reduction. The principle of laser hair removal is selective photothermolysis. The wavelength of 810nm, 755nm, and 1064nm would be able to effectively penetrate deep into and be absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system. The proposed device includes a power supply system, delivery system, control system, cooling system, and laser system. The 755nm, 810nm, and 1064nm handpieces with different treatment sizes are available for different models.
Summary parsed at:2026-06-01 05:47:45 UTC
Predicate devices
1Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules
K200118 references 1 predicate/reference device
Cited as predicate
1Multi-function Platform Systems (BL-M10)
1 submission cite K200118 as a predicate
