The Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Device Description

The Laser Treatment 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 at the wavelength of 808 nm. 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 diode laser operates in a pulsed mode with a fixed pulse width and fixed pulse duration of the pulse train for each mode. The number of pulses can be adjusted within the preset range.

The Laser Treatment System includes two (2) models, NYX and Grace, the differences between them are the external shape and the numbers of the handpiece connectors, NYX is the desktop type with one handpiece connector, and Grace is vertical stand type with two handpiece connectors.

AI/ML Overview

This FDA 510(k) summary describes a Laser Treatment System (Models: NYX and Grace) intended for hair removal and permanent hair reduction. The document focuses on demonstrating substantial equivalence to a predicate device (Diode Laser Treatment System, K182924) through non-clinical performance testing.

Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

The documents do not explicitly present a table of "acceptance criteria" for clinical effectiveness in the context of hair removal/permanent hair reduction and corresponding "reported device performance." Instead, the acceptance criteria are largely implied by compliance with recognized standards for safety and the demonstration of equivalent technological characteristics to the predicate device.

The closest we get to performance criteria are the "Indications for Use":

"The Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin."
"Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime."

However, the provided text does not contain data or study results demonstrating that the device meets this specific performance definition (i.e., measured hair reduction at 6, 9, and 12 months). The summary only describes non-clinical performance testing for safety and software.

Table summarizing implied acceptance criteria (primarily safety and technical equivalence) and their reported fulfillment:

Acceptance Criterion (Implied)	Reported Device Performance
Biocompatibility: Safe for skin contact.	Comply with ISO 10993-1:2009 for "Surface – intact skin" with "Limited (< 24 hours)" contact duration. Tests performed: Cytotoxicity, Irritation, Sensitization. All evaluation acceptance criteria were met. Patient contact material: Sapphire in handpiece and handpiece tip (stainless steel).
Electrical Safety: Meets electrical safety standards.	Comply with IEC 60601-1:2012 (General Requirements For Basic Safety And Essential Performance) and IEC 60601-2-22:2007 + A1:2012 (Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment).
Electromagnetic Compatibility (EMC): Meets EMC standards.	Comply with IEC 60601-1-2:2014 (Collateral standard: Electromagnetic compatibility- Requirements and tests).
Laser Safety: Meets laser safety standards.	Comply with IEC 60825-1: 2007 (Safety of laser products Part 1: Equipment classification and requirements) and IEC 60601-2-22:2007 + A1:2012 (Particular Requirements For Basic Safety And Essential Performance Of Surgical, Cosmetic, Therapeutic And Diagnostic Laser Equipment).
Software Validation & Verification: Software functions as intended.	Underwent software verification and validation, with results demonstrating that the software is appropriate for release. System verification testing confirmed that the system performs as intended, and that the energy outputs of the device meet specifications.
Technical Equivalence to Predicate Device (K182924):	The device "has the same technological characteristics and fundamental design as the predicate device". Similarities: Indications for Use, Operation principle (Melanin absorption), Laser type (Diode laser), Laser classification (Class IV), Laser wavelength (808nm), Spot Size (1.44 cm²), Fluence (ranges differ slightly but overlapping), Frequency (1-10Hz), Pulse Duration (10-300ms), Power supply (100-240V AC, 50/60Hz), Patient contact material, Biocompatibility, Electrical Safety, EMC, Laser safety standards. The differences identified "do not alter suitability of the proposed device for its intended use."
Clinical Effectiveness (Hair Reduction): Demonstrated long-term stable reduction in hair regrowth.	Not directly reported in this document. The provided document focuses on foundational safety and technical equivalence to establish substantial equivalence for the 510(k) clearance, not a de novo clinical study demonstrating the efficacy of its hair reduction claim. The basis for the effectiveness claim relies on the predicate device's established efficacy and the substantial equivalence shown through non-clinical tests.

Important Note: This 510(k) primarily demonstrates substantial equivalence to a predicate device, meaning it is as safe and effective as a device already on the market. It is not a de novo submission that requires extensive clinical trials to prove efficacy for the first time. The efficacy of laser hair removal devices is generally well-established in the medical literature, and clearance often relies on demonstrating that a new device operates similarly and safely.

The subsequent questions relate to clinical studies and ground truth establishment, which are not explicitly detailed in this 510(k) summary for the subject device. The document primarily focuses on non-clinical testing for safety and technical characteristics to demonstrate substantial equivalence to a predicate device.

2. Sample size used for the test set and the data provenance: Not applicable. No clinical test set data for efficacy is provided for the subject device in this document, as the submission relies on substantial equivalence. The testing mentioned (biocompatibility, electrical safety, EMC, software) are non-clinical, controlled tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No clinical test set for efficacy requiring expert ground truth is described for the subject device.

4. Adjudication method for the test set: Not applicable. (See #3)

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: Not applicable. This device is a laser treatment system, 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. (See #5)

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc): Not applicable for clinical efficacy data for the subject device. For the non-clinical tests, the "ground truth" is defined by the standards (e.g., ISO 10993-1 for biocompatibility, IEC 60601 series for safety) and the device's design specifications for energy output and software functionality.

8. The sample size for the training set: Not applicable. This document does not describe a machine learning algorithm that requires a training set. The "software verification and validation" refers to traditional software engineering testing.

9. How the ground truth for the training set was established: Not applicable. (See #8)

Summary

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February 26, 2021

Canadian Pioneer Medical Technology Corporation Dr. Rashid Reza Mir Savah Managing Director Unit 2, 210 Drumlin Circle Concord, Vaughan, Ontario L4K 3E3 CAN

Re: K210033

Trade/Device Name: Laser Treatment System, Model: NYX and Grace 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: December 24, 2020 Received: January 5, 2021

Dear Dr. Rashid Reza Mir 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 and Part 809); 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.

Purva Pandya 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) K210033

Device Name

Laser Treatment System, Model: NYX and Grace

Indications for Use (Describe)

The Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary: K210033

l. Submitter

Canadian Pioneer Medical Technology Corporation Unit 2-210 Drumlin Circle, Vaughan, Ontario, L4K 3E3, Canada

Contact person: Dr. Rashid Reza Mir Sayah Managing Director Phone: 4377727788 Email: Canadianpioneer@yahoo.com Canadianpioneer@gmail.com Info@Canadianlasers.com Date of preparation: Feb.20th, 2021

II. Subject Device

Trade Name of Device: Laser Treatment System, Model: NYX and Grace Common name: Powered Laser Surgical Instrument Classification Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulation Number: 21 CFR 878.4810 Regulatory Class: II Product code: GEX Review Panel: General & Plastic Surgery

III. Predicate Devices

Trade Name of Device: Diode Laser Treatment System Manufacturer: Weifang KM Electronics Co., LTD" Common name: Powered Laser Surgical Instrument Requlation Number: 21 CFR 878.4810 Requlatory Class: II Product code: GEX Review Panel: General & Plastic Surgery 510(k) number: K182924

IV. Device description

The Laser Treatment 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

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beam at the wavelength of 808 nm. 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 diode laser operates in a pulsed mode with a fixed pulse width and fixed pulse duration of the pulse train for each mode. The number of pulses can be adjusted within the preset range.

V. Indications for use

The Laser Treatment System is intended for hair removal, permanent hair reduction on all skin types (Fitzpatrick skin type I-VI), including tanned skin.

Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime.

VI. Comparison of technological characteristics with the predicate devices

The Laser Treatment System has the same technological characteristics and fundamental design as the predicate device. The subject device and the predicate devices are all designed for hair removal on different parts of the differences between the subject device and predicate devices do not alter suitability of the proposed device for its intended use.

Device feature	Laser Treatment System, Model:NYX and Grace (K210033)	Diode Laser Treatment System(K182924)
Manufacturer	Canadian Pioneer MedicalTechnology Corporation	Weifang KM Electronics Co., Ltd.
Product code	GEX	GEX
Regulationnumber	21 CFR 878.4810	21 CFR 878.4810
Indications foruse	The Laser Treatment System isintended for hair removal,permanent hair reduction on all skintypes (Fitzpatrick skin type I-VI),including tanned skin. Permanenthair reduction is defined as thelong-term, stable reduction in thenumber of hairs regrowing whenmeasured at 6, 9, and 12 monthsafter the completion of a treatment	The Diode Laser Treatment Systemis intended for hair removal,permanent hair reduction on all skintypes (Fitzpatrick skin type I-VI),including tanned skin. Permanenthair reduction is defined as thelong-term, stable reduction in thenumber of hairs regrowing whenmeasured at 6, 9, and 12 monthsafter the completion of a treatment

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	regime.	regime.
Operation principle	Melanin could absorb the energyfrom the laser, which would result intemperature rapid increase, todestroy surrounding hair follicles,and finally remove hair.	Melanin could absorb the energyfrom the laser, which would result intemperature rapid increase, todestroy surrounding hair follicles,and finally remove hair.
Laser type	Diode laser	Diode laser
Laser classification	Class IV	Class IV
Laser wavelength	808nm	808nm
Spot Size	1.44 cm²	1.44 cm²
Fluence	1-120J/cm²	2-120J/cm²
Frequency	1-10Hz	1-10Hz
Pulse Duration	10-300ms	10-300ms
Power supply	100-240V AC, 50/60Hz	100-240V AC, 50/60Hz
Patient contact material	Sapphire in handpiece andhandpiece tip (stainless steel)	Sapphire in handpiece andhandpiece tip (stainless steel)
Biocompatibility	Comply with ISO10993-1	Comply with ISO10993-1
Electrical Safety	Comply with IEC60601-1,IEC60601-2-22	Comply with IEC60601-1,IEC60601-2-22
EMC	Comply with IEC 60601-1-2,	Comply with IEC60601-1-2,
Laser safety	Comply with IEC60825-1,IEC60601-2-22	Comply with IEC60825-1,IEC60601-2-22

VII Summary of Non-clinical Performance Testing

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

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IEC 60601-1-2:2014, Medical electrical equipment- Part 1-2: General requirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility- Requirements and tests.

Bench Testing

IEC 60601-2-22:2007 + A1:2012, 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.

Software Validation and Verification Testing

The Laser Treatment System also underwent software verification and validation, with results demonstrating that the software is appropriate for release. System verification testing further confirmed that the system performs as intended, and that the energy outputs of the device meet specifications.

VIII Conclusion

The non-clinical testing demonstrates that the device is as safe, as effective and performs as well as the legally marketed device (K182924).

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.