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.

Device Description

The Quadruple Laser System consists of the main unit and a hand piece. The system uses a diode laser as an active medium placed in an optical cavity to produce amplified beam. A microprocessor is used to control electronics for the front panel. A self-contained water cooling system is built into the power supply unit.

The Laser treatment 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 808nm, 755, and 1064nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system.

The proposed device includes power supply system, control system, control system, cooling system, laser system.

The 755nm, 808 nm, 1064nm handpieces with different treatment sizes are available for different models.

AI/ML Overview

The Quadruple Laser System (Models: CPMT ARES, CPMT NEMESIS, CPMT NYX PLUS, CPMT GRACE PLUS) obtained 510(k) clearance (K222915) through demonstrating substantial equivalence to predicate devices (K211722 and K172193). The review was based on non-clinical performance data.

1. Table of Acceptance Criteria and Reported Device Performance

Test Category	Acceptance Criteria	Reported Device Performance
Biocompatibility	Compliance with ISO 10993-1:2009 for "Surface – intact skin" (contact < 24 hours), specifically meeting criteria for Cytotoxicity, Irritation, and Sensitization.	All evaluation acceptance criteria were met.
Electrical Safety	Compliance with IEC 60601-1:2012, IEC 60601-2-22:2007.	The system has been tested to comply with these standards.
Electromagnetic Compatibility (EMC)	Compliance with IEC 60601-1-2:2007.	The system has been tested to comply with this standard.
Laser Safety	Compliance with IEC 60825-1: 2007, IEC 60601-2-22:2007.	The system has been tested to comply with these standards.

2. Sample Size Used for the Test Set and Data Provenance

The provided document describes non-clinical performance data (biocompatibility, electrical safety, EMC, laser safety) rather than clinical study data involving patient samples. Therefore, the concept of a "test set" in the context of clinical images or patient data is not applicable here.

Sample Size: Not applicable for non-clinical testing.
Data Provenance: The document does not specify the country of origin for the non-clinical test data. It only states that the testing was performed. These tests are typically conducted in a laboratory setting.
Retrospective/Prospective: Not applicable for non-clinical testing.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Experts

Not applicable. The non-clinical tests rely on established international standards (ISO, IEC) rather than expert consensus on ground truth for individual cases. The "ground truth" for these tests is defined by the technical specifications and criteria within the respective standards.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies in expert interpretations (e.g., of medical images). This document describes non-clinical engineering and safety tests, which do not involve such adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, If So, What Was the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

No MRMC comparative effectiveness study was done. This device is a laser system for dermatologic and general surgical procedures, not an AI-powered diagnostic or assistive tool for human readers.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

Not applicable. This device is a hardware laser system, not a software algorithm.

7. The Type of Ground Truth Used

For biocompatibility, electrical safety, EMC, and laser safety, the "ground truth" is defined by the specific requirements and test methods outlined in the cited international standards (ISO 10993-1, IEC 60601-1, IEC 60601-2-22, IEC 60825-1, IEC 60601-1-2). Compliance with these standards indicates that the device is safe and performs as intended.

8. The Sample Size for the Training Set

Not applicable. This device is a physical laser system, not an AI model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As this is not an AI device, there is no training set or associated ground truth establishment process for training.

Summary

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November 15, 2022

Canadian Pioneer Medical Technology Corporation (CPMT LASER) Rashid Sayah Managing Director 210 Drumlin Circle #2, Concord Vaugham. Ontario L4K 3E3 Canada

Re: K222915

Trade/Device Name: Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE PLUS Regulation Number: 21 CFR 878.4810 Regulation Name: Laser surgical instrument for use in general and plastic surgery and in dermatology Regulatory Class: Class II Product Code: GEX Dated: September 26, 2022 Received: September 26, 2022

Dear Rashid Sayah:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jianting Wang -S

Jianting Wang Acting Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known)

K222915

Device Name

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

Indications for Use (Describe)

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 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.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) summary

K222915

I Submitter

Canadian Pioneer Medical Technology Corporation (CPMT LASER) 210 Drumlin Circle#2 , Vaughan, Ontario, L4K 3E3, Canada

Contact person: Dr. Rashid Reza Mir Sayah Managing Director Phone: 4377727788 Email: Canadianpioneer@yahoo.com Canadianpioneermedical@gmail.com Date of preparation: Sep 17, 2022

II Subject Device

Trade Name of Device: The Quadruple Laser System, Model: CPMT Nyx Plus , CPMT Grace Plus, CPMT ARES, CPMT NEMESIS Common name: Powered Laser Surgical Instrument Regulation Number: 21 CFR 878.4810 Regulatory Class: II Product code: GEX Review Panel: General & Plastic Surgery

III Predicate Devices

Trade Name of Device: Nyx plus , Grace Plus , Ares , Nemesis Common 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, SopranoXLi, Soprano ICE and Soprano ICE Platinum] with Trio Diode Laser Module

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Common 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 Laser treatment 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 808nm, 755, and 1064nm would be able to effectively penetrate deep into and absorbed by the target chromophore. The laser power is delivered to the treatment region via a delivery system.

The proposed device includes power supply system, control system, control system, cooling system, laser system.

The 755nm, 808 nm, 1064nm handpieces with different treatment sizes are available for different models.

V 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 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.

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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.

VI Comparison of technological characteristics with the predicate devices

The indication of proposed device is covered by the predicated devices. The proposed device is intended to use for hair removal on all skin types and Benign Vascular lesions and vascular dependent lesions removal.

The device includes four models for clearance in this submission. The differences between models are on their appearance and number of the connectors.These models are covered by the predicated devices.

Device feature	Quadruple LaserSystemmodels CPMT Nyx plus,CPMT Grace plus,CPMT Nemesis, CPMTAres (K222915)	Laser treatment system ,models Nyx plus, Graceplus, Nemesis, Ares(K211722)	Alma Lasers Sopranofamily(K172193)
Product code	GEX	GEX	GEX
Regulationnumber	21 CFR 878.4810	21 CFR 878.4810	21 CFR 878.4810
Manufacturer	CPMT LASER(Canadian Pioneer MedicalTechnology Corporation)	CPMT LASER(Canadian Pioneer MedicalTechnology Corporation)	Alma Lasers Inc.
Indications for use:The SimultaneousTriple WavelengthHandpiece(755/808/1064)nm	intended for use indermatology proceduresrequiring coagulation.The indications for use forthe Triple wavelengthhandpiece include:• Benign vascular andvascular dependent	intended for use indermatology proceduresrequiring coagulation.The indications for use forthe Triple wavelengthhandpiece include:• Benign vascular andvascular dependent	intended for use indermatology proceduresrequiring coagulation.The indications for use forthe Triple wavelengthhandpiece include:• Benign vascular andvascular dependent
	lesions removal.	lesions removal.	lesions removal.

The indications foruse for theHandpiece of1064nm	• The Hair Removal isintended for permanentreduction in hairregrowth defined as along term, stablereduction in the numberof hairs re-growingwhen measured at 6, 9and 12 months afterthe completion of atreatment regimen.• Treatment of Pseudofolliculitis Barbae(PFB)• Use on all skin types(Fitzpatrick I-VI),including tanned skin.	N/A	• Permanent reduction inhair regrowth in HR andSHR Mode• Treatment of Pseudofolliculitis Barbae(PFB)• Use on all skin types(Fitzpatrick I-VI),including tanned skin








The indications foruse for thehandpiece of 808nm	• The Hair Removal (HR)is intended for permanentreduction in hairregrowth defined as along term, stablereduction in the numberof hairs re-growing whenmeasured at 6, 9 and 12months after thecompletion of a treatmentregimen.• The treatment of benignvascular and pigmentedlesions.• Use on all skin types(Fitzpatrick I-VI)	N/A	(810nm):• The Hair Removal (HR)and Super Hair Removal(SHR) Mode areintended for permanentreduction in hairregrowth defined as along term, stablereduction in the numberof hairs re-growing whenmeasured at 6,9 and 12months after thecompletion of a treatmentregimen.• The treatment of benignvascular and pigmented






	including tanned skin.		lesions.(The LaserBlanch (LB) Mode)• Use on all skin types(Fitzpatrick I-VI),including tanned skin.(HR, SHR and LBModes)
The indications foruse for theHandpiece of 755 nm	The Hair Removal (HR) isintended for permanentreduction in hair regrowthdefined as a long term, stablereduction in the number ofhairs re-growing whenmeasured at 6,9 and 12months after the completionof a treatment regimen.- The treatment of benignvascular and pigmentedlesions.- Use on all skin types(Fitzpatrick I-VI), includingtanned skin.	N/A	• The Hair Removal (HR)and Super Hair Removal(SHR) Mode areintended for permanentreduction in hairregrowth defined as along term, stablereduction in the numberof hairs re-growing whenmeasured at 6,9 and 12months after thecompletion of a treatmentregimen.• The treatment of benignvascular and pigmentedlesions.(The LaserBlanch Mode)• Use on all skin types(Fitzpatrick I-VI),including tannedskin.(HR, SHR and LaserBlanch Modes)
Laser classification	Class IV	Class IV	Class IV
755nm handpiece	Laser medium: Semi-conductor	N/A	Laser medium: solid state
	Spot size: 1212 mm(optional 1527 mm)		Spot size: 15*10mm(1.5cm2)
			Pulse duration: 3.3-200ms

	Pulse duration: 1-400 msEnergy density (fluence):Up to 120 J/cm² at 1212 mm(Fluence up to 42 J/cm² at optional 1527 mm )Repetition rate: 0.5-10 Hz		Energy density (fluence)[HR]:2-120 J/cm²Repetition rate [HR]: 0.5-3 Hz
808nm nm handpiece	Laser medium: Semi conductorSpot size: 1212 mm(optional 1527 mm)Pulse duration: 1-400 msEnergy density (fluence):Up to 120 J/cm² at 1212 mm(Fluence up to 42 J/cm² at optional 1527 mm )Repetition rate: 0.5-10 Hz	N/A	(810nm):Laser medium: solid stateSpot size: 1210mm (1.2cm²)2010 mm (2cm²)Pulse duration: 3.3-200msEnergy density (fluence)[HR]:2-120 J/cm²Frequency [HR]: 0.5-3 Hz
1064nm wavelength	Laser medium: Semi conductorSpot size: 1212 mm(optional 1527 mm)Pulse duration: 1-400 msEnergy density (fluence):Up to 120 J/cm² at 1212 mm(Fluence up to 42 J/cm² at optional 1527 mm )	N/A	Laser medium: Solid stateSpot size: 10mm*10mm (1cm2) ; Optional tapered tip 6mm (0.28 cm2)Pulse duration: 3.3-280msEnergy density (fluence)[HR]:2-120 J/cm²Frequency: 0.5-3 Hz (HR),5-10 Hz(SHR): 2 Hz(LB)
	Repetition rate: 0.5-10 Hz
Simultaneoustriple-wavelengthhandpiece(755/808/1064nm)	Spot size: 1212 mm(optional 1527 mm)Pulse duration: 1-400msEnergy density (fluence):Up to 120 J/cm2 at 1212 mm(Fluence up to 42 J/cm2 at optional 1527 mm )Repetition rate: 0.5-10 Hz	Spot size: 1212 mm(optional 1527 mm)Pulse duration: 5-300ms(400 optional)Energy density (fluence):Up to 120 J/cm2Repetition rate: 1-10 H	755/810/1064 nm (Trio):Spot size: n/aPulse duration: n/aEnergy density (fluence):n/aRepetition rate: n/a
Power supply	100-240V AC,50/60Hz	100-240V AC,50/60Hz	100-240V AC,50/60Hz
Biocompatibility	Comply withISO10993-1	Comply withISO10993-1	Comply withISO10993-1
Electrical Safety	Comply withIEC60601-1,IEC60601-2-22	Comply withIEC60601-1,IEC60601-2-22	Comply with IEC60601-1,IEC60601-2-22
EMC	Comply withIEC60601-1-2	Comply withIEC60601-1-2	Comply with IEC60601-1-2
Laser safety	Comply withIEC60825-1,IEC60601-2-22	Comply withIEC60825-1,IEC60601-2-22	Comply with IEC60825-1,IEC60601-2-22

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VII Performance data

The following performance data were provided in support of the substantial equivalence

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determination.

Biocompatibility testing

Biocompatibility of the Laser Treatment System was evaluated in accordance with ISO 10993-1:2009 for the body contact category of "Surface –intact skin" with a contact duration of "Limited (< 24 hours)". The following tests were performed, as recommended: Cytotoxicity, Irritation and Sensitization. All evaluation acceptance criteria were met

Electrical safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the Laser Treatment System. The system has been tested to comply with the following standards:

IEC 60601-1:2012 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-2-22:2007, Medical Electrical Equipment Part 2-22: Particular -Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment;
-IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
-IEC 60601-1-2:2007, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.

VIII Conclusion

The Quadruple Laser System is substantially equivalent to its predicate devices. The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device.

Regulation Number and Section

§ 878.4810 Laser surgical instrument for use in general and plastic surgery and in dermatology.

(a)
Identification. (1) A carbon dioxide laser for use in general surgery and in dermatology is a laser device intended to cut, destroy, or remove tissue by light energy emitted by carbon dioxide.(2) An argon laser for use in dermatology is a laser device intended to destroy or coagulate tissue by light energy emitted by argon.
(b)
Classification. (1) Class II.(2) Class I for special laser gas mixtures used as a lasing medium for this class of lasers. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 878.9.