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.)

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. 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.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical laser device, specifically the Alexandrite and Nd:YAG Laser models CANLASE and TORLASE. The FDA's letter states that the device is substantially equivalent to a legally marketed predicate device (GentleMax Pro Plus, K201111). The document primarily focuses on demonstrating this substantial equivalence through comparison of technological characteristics and performance data related to safety standards.

Regarding the specific requests for acceptance criteria and study details, it's important to note an inherent limitation of this type of regulatory document:

This is a 510(k) summary, not a clinical study report. A 510(k) demonstrates substantial equivalence to a predicate device, often relying on existing knowledge of the predicate device's safety and effectiveness, and non-clinical performance testing of the new device. It generally does not include detailed clinical trials with specific acceptance criteria for efficacy in the way a PMA (Premarket Approval) submission would.
The "performance data" section primarily addresses safety standards. The performance data explicitly mentioned are for biocompatibility, electrical safety, and electromagnetic compatibility (EMC), not clinical effectiveness for the stated indications.

Therefore, many of the requested details about acceptance criteria for clinical performance, sample sizes for test/training sets, expert involvement, and ground truth are not present in this document or are not applicable in the context of a 510(k) for this type of device.

However, I can extract the information that is available:

1. A table of acceptance criteria and the reported device performance:

The document provides a comparison of technological characteristics and states that the device complies with certain safety standards. It does not list specific clinical acceptance criteria for efficacy (e.g., a specific percentage of hair reduction) for the subject device or its reported performance against such criteria. Instead, it relies on the substantial equivalence of its indications for use and technological characteristics to a predicate device already on the market.

Feature / Standard	Acceptance Criteria (from predicate or general standards)	Subject Device Performance
Biocompatibility	ISO 10993 for "Surface - intact skin"	Met all evaluation acceptance criteria (Cytotoxicity, Irritation, Sensitization)
Electrical Safety	IEC 60601-1, IEC 60601-2-22	Complies with these standards
Laser Safety	IEC 60825-1	Complies with this standard
Electromagnetic Compatibility (EMC)	IEC 60601-1-2	Complies with this standard
Product Code	GEX (matches predicate)	GEX
Regulation Number	21 CFR 878.4810 (matches predicate)	21 CFR 878.4810
Regulatory Class	Class II (matches predicate)	Class II
Laser Type	Alexandrite and Nd:YAG laser (matches predicate)	Alexandrite and Nd:YAG laser
Laser Classification	Class IV (matches predicate)	Class IV
Wavelength	755 & 1064 nm (matches predicate)	755 & 1064 nm
Spot Size	1.5-26 mm range (matches predicate)	1.5–26 mm range
Frequency	1-10 Hz (predicate)	0.5-10Hz
Maximum Energy (J)	Predicate: 68 J ALEX; 90 J Nd:YAG	Subject: 60 J ALEX (optional 70 J); 110 J Nd:YAG
Accuracy of Output	$\pm$ 20% (matches predicate)	$\pm$ 20%
Pulse Duration	0.25-100 ms (matches predicate)	0.25-100 ms
System Cooling	Ambient Air (matches predicate)	Ambient Air

Note on Efficacy Acceptance Criteria: The document does not state explicit quantitative clinical acceptance criteria (e.g., "70% hair reduction in 3 months") or report the device's performance against such criteria. The "indications for use" themselves serve as the qualitative efficacy claims, which are deemed substantially equivalent to the predicate device. For hair reduction, the definitions are provided (e.g., "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, no specific clinical study data is presented to quantify this for the subject device.

2. Sample size used for the test set and the data provenance:

Sample size for test set: Not applicable for a clinical test set from this document. The "performance data" section refers to non-clinical (biocompatibility, electrical safety, EMC) testing, not clinical studies on human subjects.
Data provenance: For the non-clinical tests, the data would originate from the manufacturer's testing facilities (Canadian Pioneer Medical Technology Corporation). No country of origin for clinical data is specified as no clinical data is presented.
Retrospective or prospective: Not applicable as no clinical study data is presented.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable as no clinical study data requiring ground truth establishment by experts is presented.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

Not applicable as no clinical study data requiring adjudication is presented.

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 is a laser device, not an AI-assisted diagnostic device, and no MRMC study or AI component is mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a laser device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

Not applicable as no clinical study data requiring ground truth is presented. For the non-clinical tests, the "ground truth" is compliance with established international safety standards (e.g., IEC, ISO).

8. The sample size for the training set:

Not applicable as no algorithm or training set for clinical performance is mentioned.

9. How the ground truth for the training set was established:

Not applicable as no algorithm or training set is mentioned.

In summary: This 510(k) notification demonstrates substantial equivalence primarily through comparing the technical specifications and intended uses of the new device to a predicate device, and by showing compliance with relevant safety and performance standards through non-clinical testing. It does not contain the detailed clinical efficacy study data with specific acceptance criteria, expert involvement, or ground truth that would be found in a PMA submission or a full clinical trial report.

The "study that proves the device meets the acceptance criteria" in this context refers to the non-clinical performance data (biocompatibility, electrical safety, EMC) that demonstrates the device meets the specified safety and performance standards, and comparison of its technological characteristics and indications for use to a legally marketed predicate device to establish substantial equivalence.

Summary

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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: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

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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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,

Image /page/1/Picture/5 description: The image shows the name "Jianting Wang -S" in a large, sans-serif font. The text is black against a white background. The letters are clearly legible and evenly spaced.

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:

Treatment of benign pigmented lesions.

Treatment of wrinkles.

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

1064nm:

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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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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: 4377727788 Email: Canadianpioneer@yahoo.com Canadianpioneermedical@gmail.com 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(K201111)
Product code	GEX	GEX
Manufacturer	Canadian Pioneer MedicalTechnology corporation (CPMTLASER)	Candela Corp.
Regulationnumber	21 CFR 878.4810	21 CFR 878.4810
Indications foruse	755nm:Temporary hair reduction. Stablelong-term or permanent reductionthrough selective targeting ofmelanin in hair follicles. Permanenthair reduction is defined aslong-term stable reduction in thenumber of hairs regrowing after atreatment regime. Permanent hairreduction is defined as thelong-term, stable reduction in thenumber of hairs regrowing whenmeasured at 6, 9, and 12 monthsafter the completion of a treatmentregime. On all skin types(Fitzpatrick I- VI) including tannedskin.Treatment of benign pigmentedlesions. Treatment of wrinkles.The photocoagulation ofdermatological vascular lesions(such as port-wine stains,hemangiomas, telangiectasias).1064nm:Removal of unwanted hair, forstable long term or permanent hairreduction and for treatment of PFB.Permanent hair reduction isdefined as the long-term, stablereduction in the number of hairsregrowing when measured at 6, 9	755nm:Temporary hair reduction.Stable long-term or permanentreduction through selectivetargeting of melanin in hairfollicles. Permanent hairreduction is defined aslong-term stable reduction inthe number of hairs regrowingafter a treatment regime.Permanent hair reduction isdefined as the long-term,stable reduction in the numberof hairs regrowing whenmeasured at 6, 9, and 12months after the completion ofa treatment regime. On all skintypes (Fitzpatrick I- VI)including tanned skin.Treatment of benignpigmented lesions. Treatmentof wrinkles.The photocoagulation ofdermatological vascularlesions (such as port-winestains, hemangiomas,telangiectasias).1064nm:Removal of unwanted hair, forstable long term or permanenthair 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
responded to to other laser	blue-black tattoos) and
treatments.	plaques.
Reduction of red pigmentation in	The laser is indicated for
hypertrophic and keloid scars	pigmented lesions to reduce
where vascularity is an integral	lesion size, for patients with
part of the scar. Treatment of	lesions that would potentially
wrinkles.	benefit from aggressive
Temporary increase of clear nail in	treatment, and for patients
patients with onychomycosis (e.g.,	with lesions that have not
dermatophytes, Trichophyton	responded to other laser
rubrum and T. mentagrophytes,	treatments.
and/or yeast Candida Albicans,	Reduction of red pigmentation
etc.)	in hypertrophic and keloid.
		scars where vascularity is anintegral part of the scar.Treatment of wrinkles.Temporary increase of clearnail in patients withonychomycosis (e.g.,dermatophytes, Trichophytonrubrum and T.mentagrophytes, and/or yeastCandida Albicans, etc.)
Laser Type	Alexandrite and Nd:YAG laser	Alexandrite and Nd:YAG laser
Laserclassification	Class IV	Class IV
Wavelength	755 & 1064	755 & 1064
Spot Size	1.5 mm, 3 mm, 3x10 mm, 5 mm, 6mm, 8 mm, 10 mm, 12 mm, 15mm, 18 mm, 20 mm, 22 mm, 24mm, 26 mm	1.5 mm, 3 mm, 3x10 mm, 5mm, 6 mm, 8 mm, 10 mm, 12mm, 15 mm, 18 mm, 20 mm,22 mm, 24 mm, 26 mm
Frequency	0.5 - 10Hz	1-10 Hz
MaximumEnergy (J)	60 Joules (J) ALEX(optional 70 J) ; 110J Nd:YAG	68 Joules (J) ALEX; 90 J Nd:YAG
AccuracyofOutput	$ \pm $ 20%	$ \pm $ 20%
Pulse Duration	0.25 – 100 ms	0.25 – 100 ms
SystemCooling	Ambient Air	Ambient Air
ElectricalSafety	Comply with IEC60601-1,IEC60601-2-22	Comply with IEC60601-1,IEC60601-2-22
EMC	Comply with IEC60601-1-2,	Comply with IEC60601-1-2,
Laser safety	Comply with IEC60825-1	Comply with IEC60825-1

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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 for the body contact category of "Surface -intact skin" 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 Medical Electrical Equipment - Part 1: General Requirements For Basic Safety And Essential Performance;
IEC 60601-2-22, 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, Safety of laser products - Part 1: Equipment classification and requirements.
-IEC 60601-1-2 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 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.