Shanghai Apolo Medical Technology Co., Ltd.
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
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)
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.
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
Modified 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
Multi-function Platform Systems (BL-M10)
1 submission cite K200118 as a predicate
