Canadian Pioneer Medical Technology Corporation
Product code GEX· 21 CFR 878.4810
Product code
FDA 510(k) registration fields
The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for: - Benign vascular lesions and vascular dependent lesions removal
The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for benign vascular lesions and vascular dependent lesions removal.
The laser treatment system includes four models of machines and the simultaneous triple wavelength applicator for all four models. The Simultaneous triple-wavelength laser device (trio) operates at wavelengths of 755-808-1064 nm. It is classified as Class IV and complies with various safety and performance standards including ISO 10993-1 and IEC 60601.
Summary parsed at:2026-06-01 05:38:17 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
K211722 references 1 predicate/reference device
Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS
Canadian Pioneer Medical Technology Corporation (Cpmt Laser)
1 submission cite K211722 as a predicate
