Manufacturer
Canadian Pioneer Medical Technology CorporationLaser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
Canadian Pioneer Medical Technology Corporation
Country / Region:Canada (CA)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
- K211722
- Device name
- Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
- Country / Region
- Canada(CA)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2021-06-04
- Decision date
- 2022-02-25
- Submission type
- Traditional
- Technology type
- Nd:YAG(AI inferred)
- Clinical applications
- Vascular treatment
- Primary application
- Vascular treatment
- Classification source
- AI classified
Indications for Use
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
Intended Use
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.
Device Description
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
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
K211722 references 1 predicate/reference device
Cited as predicate
1Quadruple 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