Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares

K211722 · Canadian Pioneer Medical Technology Corporation · GEX · Feb 25, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K211722
• Device Name: Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares
• Applicant: Canadian Pioneer Medical Technology Corporation
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Feb 25, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for : · Benign vascular lesions and vascular dependent lesions removal

Device Story

Laser Treatment System (Models: Nyx Plus, Grace Plus, Ares, Nemesis) utilizes simultaneous triple-wavelength (755, 808, 1064 nm) laser module for dermatological coagulation. System comprises main unit with integrated water cooling and handpieces. Microprocessor controls electronics and front panel interface. Operated by clinicians in dermatology settings. Laser energy targets vascular lesions; thermal effect facilitates coagulation. Benefits include removal of benign vascular and vascular-dependent lesions. Device is prescription-only.

Clinical Evidence

Bench testing only. No clinical data provided. Performance supported by biocompatibility testing (cytotoxicity, irritation, sensitization per ISO 10993-1), electrical safety (IEC 60601-1, IEC 60601-2-22), laser safety (IEC 60825-1), and EMC (IEC 60601-1-2) testing.

Technological Characteristics

Class IV laser system; simultaneous triple-wavelength (755, 808, 1064 nm) output. Features microprocessor-controlled electronics and self-contained water cooling. Biocompatibility per ISO 10993-1. Electrical/EMC compliance per IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2. Pulse duration 5-300ms (optional 400ms); frequency 1-10Hz.

Indications for Use

Indicated for the removal of benign vascular lesions and vascular dependent lesions in patients requiring dermatological coagulation procedures.

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

• 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 (K172193)

Submission Summary (Full Text)

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

February 25, 2022

Canadian Pioneer Medical Technology Corporation Rashid Reza Mir Sayah Unit 2 -210 Drumlin Circle, Concord Vaughan, Ontario L4K 3E3 Canada

Re: K211722

Trade/Device Name: Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis 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: January 17, 2022 Received: January 19, 2022

Dear Rashid Reza Mir:

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.

{1}------------------------------------------------

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 mediation-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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K211722

#### Device Name

Laser Treatment System Models: Nyx Plus, Grace Plus, Ares, Nemesis

Indications for Use (Describe)

The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for :

· Benign vascular lesions and vascular dependent lesions removal

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

| <span style="font-size:12px">☑ Prescription Use (Part 21 CFR 801 Subpart D)</span> |
|------------------------------------------------------------------------------------|
| <span style="font-size:12px">☐ Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) summary

## I Submitter

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

Contact person: Dr. Rashid Reza Mir Sayah Managing Director Phone: [phone] Email: [e-mail] Date of preparation: May 29, 2021

#### II Subject Device

Trade Name of Device: Laser Treatment System, Model: 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

### III Predicate Device

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 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 System consists of the main unit and its handpieces. The system uses laser as an active medium placed in an optical cavity to produce amplified beam at the applicators and the Simultaneous triple-wavelength of 755,808 and 1064 nm. A

{4}------------------------------------------------

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 System is designed to be used dermatology procedures requiring coagulation. The indications for use for the 3 simultaneously wavelength 755,808,1064 nm Laser Module is treatment of benign vascular and vascular dependent lesions.

### V Intended use of device and Indications for Use

### Intended Use

The Laser Treatment System, Models: Nyx Plus, Grace Plus, Ares, Nemesis, when used with the simultaneous triple wavelength module 755-808-1064 nm, is intended for : · Benign vascular lesions and vascular dependent lesions removal

### VI Comparison of technological characteristics with the predicate devices

The indication of the proposed device is covered by the predicated devices. The laser treatment system includes four models of machines and the simultaneous triple wavelength applicator for all four models.

| Device<br>feature | Laser Treatment System<br>(subject device) | Modified Alma Lasers<br>Soprano XL. Family of<br>Multi-Application &<br>Multi-Technology<br>Platforms (K172193) |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------|
| Product<br>code | GEX | GEX |
| Regulation<br>number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indications<br>for use | The indication of use of 3<br>wavelength 755,808,1064<br>handpiece (trio is<br>treatment of Benign<br>vascular lesions and<br>vascular dependent<br>lesions removal | The indication of use of trio<br>is treatment of Benign<br>vascular lesions and<br>vascular dependent lesions<br>removal |
| Laser<br>classification | Class IV | Class IV |

{5}------------------------------------------------

| Wavelength | The Simultaneous<br>triple-wavelength laser<br>device (trio)<br>755-808-1064 nm | Trio 755-808-1064 nm |
|----------------------|---------------------------------------------------------------------------------|------------------------------------------|
| Frequency | 1-10Hz | 0.5~3 Hz (HR), 5~10 Hz(SHR); 2 Hz(LB) |
| Pulse<br>Duration | 5-300 (to 400 optional) | 3.3-200ms |
| Biocompatibility | Comply with ISO10993-1 | Comply with ISO10993-1 |
| Electrical<br>Safety | Comply with IEC60601-1,<br>IEC60601-2-22 | Comply with IEC60601-1,<br>IEC60601-2-22 |
| EMC | Comply with<br>IEC60601-1-2, | Comply with IEC60601-1-2, |
| Laser safety | Comply with IEC60825-1,<br>IEC60601-2-22 | Comply with IEC60825-1,<br>IEC60601-2-22 |

### VII Performance data

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;

{6}------------------------------------------------

- IC 60601-2-22: 2007 (Third Edition) + A1:2012 for use inconjunction with IEC 60601-1: -2005 (Third Edition) + A1:2012
- -IEC 60825-1: 2007, Safety of laser products - Part 1: Equipment classification and requirements.
- 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.

# VIII Conclusion

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