Laser Treatment System, Model: NYX and Grace

K210033 · Canadian Pioneer Medical Technology Corporation · GEX · Feb 26, 2021 · General, Plastic Surgery

Device Facts

• Record ID: K210033
• Device Name: Laser Treatment System, Model: NYX and Grace
• Applicant: Canadian Pioneer Medical Technology Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 26, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended 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.

Device Story

Diode laser system (808 nm) for hair removal; utilizes melanin absorption to heat and destroy hair follicles. System comprises main unit and handpiece; NYX model is desktop with one connector; Grace model is vertical stand with two connectors. Microprocessor controls electronics and pulsed laser output; self-contained water cooling system integrated into power supply. Operated by clinicians in professional settings. Healthcare provider uses device to deliver controlled laser energy to skin; output affects hair follicle viability to achieve permanent reduction. Benefits patient through long-term hair reduction.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility testing (ISO 10993-1), electrical safety (IEC 60601-1, IEC 60601-2-22), EMC (IEC 60601-1-2), and laser safety (IEC 60825-1). Software verification and validation testing confirmed system performance and energy output specifications.

Technological Characteristics

Diode laser (808nm), Class IV. Pulsed mode operation (1-10Hz, 10-300ms pulse duration, 1-120J/cm² fluence). 1.44 cm² spot size. Materials: Sapphire handpiece, stainless steel tip. Compliance: ISO 10993-1 (biocompatibility), IEC 60601-1, IEC 60601-2-22, IEC 60601-1-2, IEC 60825-1. Microprocessor-controlled electronics with integrated water cooling.

Indications for Use

Indicated for hair removal and permanent hair reduction in patients of all skin types (Fitzpatrick I-VI), including tanned skin.

Regulatory Classification

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.

Predicate Devices

• Diode Laser Treatment System (K182924)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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) | |
|----------------------------------------------------------------------------------|---------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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: [phone] Email: [e-mail] [e-mail] [e-mail] 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.

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.

#### 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:<br>NYX and Grace (K210033) | Diode Laser Treatment System<br>(K182924) |
|------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Canadian Pioneer Medical<br>Technology Corporation | Weifang KM Electronics Co., Ltd. |
| Product code | GEX | GEX |
| Regulation<br>number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indications for<br>use | The Laser Treatment System is<br>intended for hair removal,<br>permanent hair reduction on all skin<br>types (Fitzpatrick skin type I-VI),<br>including tanned skin. Permanent<br>hair reduction is defined as the<br>long-term, stable reduction in the<br>number of hairs regrowing when<br>measured at 6, 9, and 12 months<br>after the completion of a treatment | The Diode Laser Treatment System<br>is intended for hair removal,<br>permanent hair reduction on all skin<br>types (Fitzpatrick skin type I-VI),<br>including tanned skin. Permanent<br>hair reduction is defined as the<br>long-term, stable reduction in the<br>number of hairs regrowing when<br>measured at 6, 9, and 12 months<br>after the completion of a treatment |

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| | regime. | regime. |
|--------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Operation principle | Melanin could absorb the energy<br>from the laser, which would result in<br>temperature rapid increase, to<br>destroy surrounding hair follicles,<br>and finally remove hair. | Melanin could absorb the energy<br>from the laser, which would result in<br>temperature rapid increase, to<br>destroy surrounding hair follicles,<br>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 and<br>handpiece tip (stainless steel) | Sapphire in handpiece and<br>handpiece tip (stainless steel) |
| Biocompatibility | Comply with ISO10993-1 | Comply with ISO10993-1 |
| Electrical Safety | Comply with IEC60601-1,<br>IEC60601-2-22 | Comply with IEC60601-1,<br>IEC60601-2-22 |
| EMC | Comply with IEC 60601-1-2, | Comply with IEC60601-1-2, |
| Laser safety | Comply with IEC60825-1,<br>IEC60601-2-22 | Comply with IEC60825-1,<br>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).