510(k) · Cleared
ClearedQuadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Canadian Pioneer Medical Technology Corporation (Cpmt Laser) · GEX Powered Laser Surgical Instrument
Cleared on Nov 15, 2022 as substantially equivalent to K211722 (Canadian Pioneer Medical Technology Corporation, 2022) and 1 other predicate after a 50-day review. Its family tree reaches back 25 generations to 1995.
- Decided
- Nov 15, 2022
- Review
- 50 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 25 generations to K943450 (1995). 566 ancestors in all, the oldest K771218 (1978). No later device cites it as a predicate yet.
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations between
- 3 generations backK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
- 2 generations backK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- 1 generation backK211722 Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation · 2022
- This deviceK222915 Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT…Canadian Pioneer Medical Technology Corporation (Cpmt Laser) · 2022
Show all 25 generations
- Root · 25 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 24 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 23 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 21 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 20 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 19 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 18 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 17 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 16 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 14 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 13 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 12 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 11 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 10 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 9 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 8 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 7 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 6 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 5 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 4 generations backK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
- 3 generations backK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
- 2 generations backK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- 1 generation backK211722 Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresCanadian Pioneer Medical Technology Corporation · 2022
- This deviceK222915 Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT…Canadian Pioneer Medical Technology Corporation (Cpmt Laser) · 2022
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −25 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −24 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −23 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −21 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −20 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −19 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −18 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −17 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −16 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −14 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −13 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −12 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −11 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −10 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −9 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −8 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −7 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −6 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| −5 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| −4 | K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016 | — |
| −3 | K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology… | Alma Lasers, Inc. | 2017 | — |
| −2 | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology… | Alma Lasers, Inc. | 2018 | — |
| −1 | K211722 | Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares | Canadian Pioneer Medical Technology Corporation | 2022 | — |
| 0 (this device) | K222915 | Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS… | Canadian Pioneer Medical Technology Corporation (Cpmt Laser) | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 9 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 27 | 0 |
| 1995 | 26 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 33 | 0 |
| 1999 | 29 | 0 |
| 2000 | 36 | 0 |
| 2001 | 36 | 0 |
| 2002 | 44 | 0 |
| 2003 | 48 | 0 |
| 2004 | 36 | 0 |
| 2005 | 31 | 0 |
| 2006 | 17 | 0 |
| 2007 | 17 | 0 |
| 2008 | 21 | 0 |
| 2009 | 12 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in GEX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K211722 | Laser treatment system , models Nyx plus, Grace plus, Nemesis, AresSummary page 5…name: Powered Laser Surgical Instrument Regulation Number: 21 CFR 878.4810 Regulatory Class: II Product code: GEX Review Panel: General & Plastic Surgery 510(k) number: K211722 2. Trade Name of Device: Modified Alma Lasers Soprano XLTM Family of Multi-Application and Multi-Technology Platforms [SopranoXL,… | 2022 |
| * | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Summary page 6…name: Powered Laser Surgical Instrument Regulation Number: 21 CFR 878.4810 Regulatory Class: II Product code: GEX Review Panel: General & Plastic Surgery 510(k) number: K172193 IV Device description The Quadruple Laser System consists of the main unit and a hand piece. The system uses a diode laser as… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 12 companies; a new generation was cleared every 10 months on median.
- 27 of the 566 ancestors have a recall of any class.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
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…
Read the full statement (277 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222915 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222915: Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222915
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026