Alexandrite and Nd:YAG Laser models CANLASE and TORLASE

K222673 · Canadian Pioneer Medical Technology Corporation (Cpmt Laser) · GEX · Nov 17, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K222673
• Device Name: Alexandrite and Nd:YAG Laser models CANLASE and TORLASE
• Applicant: Canadian Pioneer Medical Technology Corporation (Cpmt Laser)
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Nov 17, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

755nm: Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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. On all skin types (Fitzpatrick I- VI) including tanned skin. Treatment of benign pigmented lesions. Treatment of wrinkles. The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias). 1064nm: Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques. The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles. Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

Device Story

Dual-head laser system (Alexandrite 755nm and Nd:YAG 1064nm); optically combined beam paths; single delivery system. High-intensity light penetrates skin; delivers therapeutic heat for photocoagulation, hemostasis, and selective melanin targeting. Used in clinical settings by trained professionals. Output affects tissue via thermal energy; benefits include hair reduction, lesion clearance, scar improvement, and nail clarity. System includes laser rail and delivery handpiece.

Clinical Evidence

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

Technological Characteristics

Class IV laser system; dual-wavelength (755nm/1064nm); ambient air cooling; spot sizes 1.5-26mm; pulse duration 0.25-100ms; frequency 0.5-10Hz. Complies with IEC 60601-1, IEC 60601-2-22, IEC 60825-1, and IEC 60601-1-2 standards.

Indications for Use

Indicated for hair reduction, treatment of benign pigmented/vascular lesions, wrinkles, soft tissue coagulation/hemostasis, and onychomycosis in patients of all Fitzpatrick skin types (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

• GentleMax Pro Plus (K201111)

Submission Summary (Full Text)

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November 17, 2022

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

Re: K222673

Trade/Device Name: Alexandrite and Nd:YAG Laser models CANLASE and TORLASE 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 6, 2022 Received: September 6, 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.

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

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Sincerely,

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

Enclosure

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# Indications for Use

510(k) Number (if known) K222673

#### Device Name

Alexandrite and Nd:YAG laser models CANLASE , TORLASE

#### Indications for Use (Describe)

755mm:

Temporary hair reduction. Stable long-term or permanent reduction targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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. On all skin types (Fitzpatrick I-VI) including tanned skin.

Treatment of benign pigmented lesions.

Treatment of wrinkles.

The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

1064nm:

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment 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. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.

The laser is indicated for pigmented lesion size. for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.

Temporary increase of clear nail in patients with onychomycosis ( e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

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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# K222673

# Section 5 510(k) summary

#### l Submitter

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

Contact person: Dr. Rashid Reza Mir Sayah Managing Director Phone: [phone] Email: [e-mail] [e-mail] Date of preparation: Sep 06, 2022

#### II Subject Device

Trade/Device Name: Alexandrite Nd:YAG laser , Models: CANLASE , TORLASE Regulation Number: 21 CFR 878.4810 Requlation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: II Product code: GEX Manufacturer: Canadian Pioneer Medical Technology Corporation

### III Predicate Devices

Trade/Device Name: GentleMax Pro Plus Regulation Number: 21 CFR 878.4810 Regulation Name: Laser Surgical Instrument For Use In General And Plastic Surgery And In Dermatology Regulatory Class: II Product code: GEX 510(k) number: k201111

Manufacturer: Candela Corporation

#### IV Device description

Alexandrite Nd:YAG laser Models CPMT CANLASE , CPMT TORLASE

contain two separate laser heads (Alexandrite and Nd:YAG), which produce laser light outputs of 755 nm and 1064 nm, respectively. The output of each laser head is optically combined on the laser rail, so that their beam paths are identical as they exit the laser system.

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This allows the use of a single delivery system which can output either 755 nm or 1064 nm wavelengths. The laser system creates a beam of high intensity light that penetrates deep into the skin tissue where it delivers a controlled amount of therapeutic heat.

## V Indications for use

#### 755nm:

Temporary hair reduction. Stable long-term or permanent reduction through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as long-term stable reduction in the number of hairs regrowing after a treatment regime. 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. On all skin types (Fitzpatrick I- VI) including tanned skin.

Treatment of benign pigmented lesions. Treatment of wrinkles.

The photocoagulation of dermatological vascular lesions (such as port-wine stains, hemangiomas, telangiectasias).

### 1064nm:

Removal of unwanted hair, for stable long term or permanent hair reduction and for treatment of PFB. 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. The lasers are indicated on all skin types Fitzpatrick I-VI including tanned skin. Photocoagulation and hemostasis of pigmented and vascular lesions such as but not limited to port wine stains, hemangioma, warts, telangiectasia, rosacea, venus lake, leg veins and spider veins. Coagulation and hemostasis of soft tissue. Benign pigmented lesions such as, but not limited to, lentigos (age spots), solar lentigos (sun spots), cafe au lait macules, seborrheic keratosis, nevi, chloasma, verrucae, skin tags, keratosis, tattoos (significant reduction in the intensity of black and/or blue-black tattoos) and plaques.

The laser is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments.

Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. Treatment of wrinkles.

Temporary increase of clear nail in patients with onychomycosis (e.g., dermatophytes, Trichophyton rubrum and T. mentagrophytes, and/or yeast Candida Albicans, etc.)

# VI Comparison of technological characteristics with the predicate devices

The indication of proposed device is covered by the predicated devices.

| Device feature | | |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Alexandrite and Nd:YAG Laser | Laser treatment system |
| | (subject device) | GentleMax Family of Laser Systems<br>(K201111) |
| Product code | GEX | GEX |
| Manufacturer | Canadian Pioneer Medical<br>Technology corporation (CPMT<br>LASER) | Candela Corp. |
| Regulation<br>number | 21 CFR 878.4810 | 21 CFR 878.4810 |
| Indications for<br>use | 755nm:<br>Temporary hair reduction. Stable<br>long-term or permanent reduction<br>through selective targeting of<br>melanin in hair follicles. Permanent<br>hair reduction is defined as<br>long-term stable reduction in the<br>number of hairs regrowing after a<br>treatment regime. Permanent hair<br>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<br>regime. On all skin types<br>(Fitzpatrick I- VI) including tanned<br>skin.<br>Treatment of benign pigmented<br>lesions. Treatment of wrinkles.<br>The photocoagulation of<br>dermatological vascular lesions<br>(such as port-wine stains,<br>hemangiomas, telangiectasias).<br>1064nm:<br>Removal of unwanted hair, for<br>stable long term or permanent hair<br>reduction and for treatment of PFB.<br>Permanent hair reduction is<br>defined as the long-term, stable<br>reduction in the number of hairs<br>regrowing when measured at 6, 9 | 755nm:<br>Temporary hair reduction.<br>Stable long-term or permanent<br>reduction through selective<br>targeting of melanin in hair<br>follicles. Permanent hair<br>reduction is defined as<br>long-term stable reduction in<br>the number of hairs regrowing<br>after a treatment regime.<br>Permanent hair reduction is<br>defined as the long-term,<br>stable reduction in the number<br>of hairs regrowing when<br>measured at 6, 9, and 12<br>months after the completion of<br>a treatment regime. On all skin<br>types (Fitzpatrick I- VI)<br>including tanned skin.<br>Treatment of benign<br>pigmented lesions. Treatment<br>of wrinkles.<br>The photocoagulation of<br>dermatological vascular<br>lesions (such as port-wine<br>stains, hemangiomas,<br>telangiectasias).<br>1064nm:<br>Removal of unwanted hair, for<br>stable long term or permanent<br>hair reduction and for |
| and 12 months after the | treatment of PFB. Permanent | |
| completion of a treatment regime. | hair reduction is defined as the | |
| The lasers are indicated on all skin | long-term, stable reduction in | |
| types Fitzpatrick I-VI including | the number of hairs regrowing | |
| tanned skin. Photocoagulation and | when measured at 6, 9, and | |
| hemostasis of pigmented and | 12 months after the | |
| vascular lesions such as but not | completion of a treatment | |
| limited to port wine stains, | regime. The lasers are | |
| hemangioma, warts, | indicated on all skin types | |
| telangiectasia, rosacea, venus | Fitzpatrick I-VI including | |
| lake, leg veins and spider veins. | tanned skin. Photocoagulation | |
| Coagulation and hemostasis of soft | and hemostasis of pigmented | |
| tissue. Benign pigmented lesions | and vascular lesions such as | |
| such as, but not limited to, lentigos | but not limited to port wine | |
| (age spots), solar lentigos (sun | stains, hemangioma, warts, | |
| spots), cafe au lait macules, | telangiectasia, rosacea, venus | |
| seborrheic keratosis, nevi, | lake, leg veins and spider | |
| chloasma, verrucae, skin tags, | veins. Coagulation and | |
| keratosis, tattoos (significant | hemostasis of soft tissue. | |
| reduction in the intensity of black | Benign pigmented lesions | |
| and/or blue-black tattoos) and | such as, but not limited to, | |
| plaques. | lentigos (age spots), solar | |
| The laser is indicated for | lentigos (sun spots), cafe au | |
| pigmented lesions to reduce lesion | lait macules, seborrheic | |
| size, for patients with lesions that | keratosis, nevi, chloasma, | |
| would potentially benefit from | verrucae, skin tags, keratosis, | |
| aggressive treatment, and for | tattoos (significant reduction in | |
| patients with lesions that have not | the intensity of black and/or…