# K222915: Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS

- Pathway: 510(k) (Traditional)
- Applicant: Canadian Pioneer Medical Technology Corporation (Cpmt Laser)
- Decided: Nov 15, 2022 after 50 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 25 generations back to K943450 (1995). 566 ancestors in all.
No later device cites it as a predicate yet.
0 of 567 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211722: Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares, Canadian Pioneer Medical Technology Corporation (2022) Summary page 5.
- K172193: 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, Alma Lasers, Inc. (2018) Summary page 6.

## Indications for use
The Quadruple Laser System has 4 types of handles : 755 nm , 808nm and 1064 nm and simultaneous triple wavelength 755/808/1064nm . Intended Use The device is intended for use in dermatologic and general surgical procedures. The simultaneous triple wavelength handpiece is intended for use in dermatology procedures requiring coagulation. The indications for use for the Triple wavelength handpiece include: Benign vascular and vascular dependent lesions removal. The indications for use for the handpiece of 1064nm include: - The Hair Removal is 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. - Treatment of Pseudo folliculitis Barbae (PFB) - Use on all skin types (Fitzpatrick I-VI), including tanned skin. The indications for use for the handpiece of 808 nm include: - The Hair Removal (HR) is 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. - Use on all skin types (Fitzpatrick I-VI), including tanned skin. The indications for use for the handpiece of 755 nm include: - The Hair Removal (HR) is 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. - Use on all skin types (Fitzpatrick I-VI), including tanned skin.

Source page: https://510kreport.com/device/K222915
Methodology: https://510kreport.com/methodology