MT ONE and its Hand Pieces are intended for use in aesthetic, surgical and cosmetic applications and in selective treatments required in the medical specialties of dermatology and general and plastic surgery.

MT ONE with HR808nm Laser Handpiece is indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.

MT ONE with AC415-950nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Inflammatory Acne (acne vulgaris) in skin types (I-V) to the Fitzpatrick scale.

MT ONE with VLPL535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of benign Pigmented and Vascular Lesions in skin types (I-V) to the Fitzpatrick scale.

MT ONE with VLPL535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) with Sub-Millisecond Technology (S.M.T.) is indicated for the treatment of erythematous rosacea, Telangiectasias, PWS (Port Wine Stains) Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular lesion(eg Diffuse Redness).

MT ONE with HR580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick scale.

MT ONE with SR580-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for Treatment of Benign Pigmented Epidermal and Cutaneous Lesions including warts, scars and striae in all skin types (I-VI) to the Fitzpatrick scale.

MT ONE with HR635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick scale.

MT ONE with HR635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) In-Moving is indicated Hair removal and permanent Hair reduction in all skin types (I-VI) to the Fitzpatrick scale

MT ONE with 2940 nm Er-Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to:

Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).

MT ONE with 1064 nm Long Pulse (LP) Nd: Y AG Laser Handpiece is indicated for:

· Removal of unwanted hair, for stable long-term, or permanent, hair reduction* through selective targeting of melanin in hair follicles.

· Removal or lightening of unwanted hair (with and without adjuvant preparation)
· Treatment of pseudofolliculitis barbae (PFB)
· Benign vascular Lesions.

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.

MT ONE with 532/1064 nm Nd:YAG Q-Switch Laser Handpiece is indicated for:

· Benign vascular and pigmented lesions, age spots
Nevus spilus
Tattoo removal

MT ONE with fractional non-ablative 1540 nm Er Glass Laser Handpiece is indicated for

· Post-operative Scars, Acne Scars, Skin Resurfacing, Striae

Device Description

MT ONE is an Intense Pulsed Light (IPL) and laser emitting device that is operated with handpiece in contact with the skin.

MT ONE comprises a main console unit and several handpieces that are triggered by means of footswitch or a finger switch.

The main console of MT ONE is the same, with no modification, of the predicated devices cleared by K172413. The difference is only in the addition of 4 new handpieces, see list below.

A microprocessor based system controller is used to monitor and direct all the system function and the graphic user interface.

The main console can be connected to the following handpieces:

Handpieces that are already cleared by K172413

-HR808 nm laser diode
-AC415-950 nm Intense Pulsed Light
-VPLP535-950 nm Intense Pulsed Light
-SR580-950 nm Intense Pulsed Light
-HR580-950 nm Intense Pulsed Light
-HR635-950 nm Intense Pulsed Light
-2940 nm ERBIUM YAG laser
-1064 nm ND:YAGLP laser

Handpieces object of this submission:

532/1064 nm ND:YAG Q-Switched laser -
-Fractional non-ablative 1540 nm Er:Glass laser
-VPLP535-950 nm Intense Pulsed Light with S.M.T.
-HR635-950 nm Intense Pulsed Light In Moving

AI/ML Overview

The provided text is a 510(k) summary for the MT ONE device. It details various aspects of the device, its intended uses, and comparisons to predicate devices. However, it does not contain specific acceptance criteria, performance metrics, or study designs that would typically be found in a clinical study report. The "Performance data" section only mentions biocompatibility testing, electrical safety/EMC, and software verification/validation, which are engineering and regulatory compliance tests, not clinical performance studies.

Therefore, many of the requested details about acceptance criteria and clinical study performance cannot be extracted from this document. The document focuses on establishing substantial equivalence based on technological characteristics and safety standards rather than clinical efficacy studies with ground truth.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

Cannot be provided: The document does not specify quantitative acceptance criteria for clinical performance (e.g., sensitivity, specificity, accuracy, or specific levels of treatment success) or report device performance against such criteria. The performance data section focuses on engineering and regulatory compliance (biocompatibility, electrical safety, software V&V) rather than clinical outcomes.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Cannot be provided: The document does not describe any clinical test set or study participants. The testing mentioned is related to engineering and software, not clinical trials.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Cannot be provided: No clinical test set or ground truth establishment process is described.

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

Cannot be provided: No clinical test set or adjudication method is described.

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

Cannot be provided: This document describes a laser and IPL device for various skin treatments, not an AI-assisted diagnostic device. Therefore, an MRMC study or AI assistance is not applicable and not mentioned.

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

Cannot be provided: As mentioned above, this is not an AI algorithm but a physical medical device.

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

Cannot be provided: No clinical ground truth is described in the context of the performance data provided. The document outlines comparisons of technical specifications and intended uses to predicate devices to establish substantial equivalence.

8. The sample size for the training set

Cannot be provided: The document does not describe any machine learning or AI components that would require a training set.

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

Cannot be provided: Not applicable, as there is no mention of a training set for an AI/ML model.

Summary

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April 24, 2020

Image /page/0/Picture/1 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 & 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.

M&t Srl % Chiara Violini Consultant Endo Engineering Via Del Consorzio, 41 Falconara Marittaima, 60015 It

Re: K192856

Trade/Device Name: MT One 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, ONG, ONF, ONF, ONE Dated: September 19, 2019 Received: October 4, 2019

Dear Chiara Violini:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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

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 (OS) 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Colin Kejing Chen, Ph.D. Acting 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) K192856

Device Name MT ONE

Indications for Use (Describe)

MT ONE with HR808nm Laser Handpiece is indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.

MT ONE with 2940 nm Er-Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to:

Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).

MT ONE with 1064 nm Long Pulse (LP) Nd: Y AG Laser Handpiece is indicated for:

· Removal of unwanted hair, for stable long-term, or permanent, hair reduction* through selective targeting of melanin in hair follicles.

· Removal or lightening of unwanted hair (with and without adjuvant preparation)
· Treatment of pseudofolliculitis barbae (PFB)
· Benign vascular Lesions.

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.

MT ONE with 532/1064 nm Nd:YAG Q-Switch Laser Handpiece is indicated for:

· Benign vascular and pigmented lesions, age spots
Nevus spilus
Tattoo removal

MT ONE with fractional non-ablative 1540 nm Er Glass Laser Handpiece is indicated for

· Post-operative Scars, Acne Scars, Skin Resurfacing, Striae

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X Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/4/Picture/0 description: The image shows the logo for M & T srl medical technology. The logo features a gray circle with the letters "m", "t", and "&" inside. Below the circle, the text "M & T srl medical technology" is written in a simple, sans-serif font.

MT ONE

510(k) Summary 5

Introduction:

This document contains the 510(k) Summary for the MT ONE device. The content of this summary is based on the requirements of 21 CFR 807.92(c).

Applicant/Manufacturer Name and Address:	M&T S.R.L.Via Pietrarubbia 32/FRimini - 47900Italy
510(k) Contact Person:	Fiorenzo RossiCEO
	Email: fiorenzor@medical-technology.itPhone: +39-0541-727486
Date Prepared:	20/04/2020
Device Name:	MT ONE
Common or Usual Name:	Intense Pulsed Light(IPL) and laser System
Classification:	Class II
Classification Name:	Laser surgical instrument for use in general and plasticsurgery and in dermatology
Regulation number:	21 CFR 878.4810
Classification product code:	GEX, ONG, ONF, ONE
Predicate Devices:	Icon - PALOMAR - K110907Quanta Forte - QUANTA SYSTEM SPA - K152714OmniMax S4- SHARPLIGHT TECHNOLOGIES LTD. - K111303Harmony XI - ALMA LASERS LTD. - K072564M22 - LUMENIS LTD. - K142860MT One- M&T SRL - K172413 K150907 ELLIPSE NORDLYS + K161162 ELLIPSE FRAX 1550FOR NORDLYS- ELLIPSE A/S

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Image /page/5/Picture/0 description: The image shows a logo for M & T srl medical technology. The logo features a circular graphic with the letters 'm' and 't' intertwined in a stylized font. Below the graphic, the text 'M & T srl' is displayed on one line, followed by 'medical technology' on the next line, both in a smaller, sans-serif font.

Description of the device:

MT ONE is an Intense Pulsed Light (IPL) and laser emitting device that is operated with handpiece in contact with the skin.

MT ONE comprises a main console unit and several handpieces that are triggered by means of footswitch or a finger switch.

The main console of MT ONE is the same, with no modification, of the predicated devices cleared by K172413. The difference is only in the addition of 4 new handpieces, see list below.

A microprocessor based system controller is used to monitor and direct all the system function and the graphic user interface.

The main console can be connected to the following handpieces:

Handpieces that are already cleared by K172413

-HR808 nm laser diode
-AC415-950 nm Intense Pulsed Light
-VPLP535-950 nm Intense Pulsed Light
-SR580-950 nm Intense Pulsed Light
-HR580-950 nm Intense Pulsed Light
-HR635-950 nm Intense Pulsed Light
-2940 nm ERBIUM YAG laser
-1064 nm ND:YAGLP laser

Handpieces object of this submission:

532/1064 nm ND:YAG Q-Switched laser -
-Fractional non-ablative 1540 nm Er:Glass laser
-VPLP535-950 nm Intense Pulsed Light with S.M.T.
-HR635-950 nm Intense Pulsed Light In Moving

Intended Use:

MT ONE with HR808nm Laser Handpiece is indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.

MT ONE with VLPL535-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) with Sub-Millisecond Technology (S.M.T.) is indicated for the treatment erythematous rosacea, Telangiectasias, PWS (Port Wine Stains) Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular lesion(eg Diffuse Redness).

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Image /page/6/Picture/0 description: The image shows the logo for M & T srl medical technology. The logo consists of a gray circle with the letters "m" and "t" in white inside the circle. Below the circle is the text "M & T srl" in a smaller font, and below that is the text "medical technology" in an even smaller font. The logo is simple and professional, and it conveys the company's focus on medical technology.

MT ONE with HR635-950 nm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) In-Moving is indicated to Hair removal and permanent Hair reduction in all skin types (I-VI) to the Fitzpatrick scale.

MT ONE with 2940 nm Er-Yag Laser Handpiece is indicated for use in soft tissue (skin and cutaneous tissue) such as, but not limited to:

Skin resurfacing; Treatment of wrinkles; Epidermal nevi; Telangiectasia; Spider veins; Actinic chelitis; Keloids; Verrucae; Skin tags; Anal tags; Keratoses; Scar revision (including acne scars).

MT ONE with 1064 nm Long Pulse (LP) Nd:YAG Laser Handpiece is indicated for:

Removal of unwanted hair, for stable long-term, or permanent, hair reduction* through selective targeting of melanin in hair follicles.
Removal or lightening of unwanted hair (with and without adjuvant preparation) 0
0 Treatment of pseudofolliculitis barbae (PFB)
0 Benign vascular Lesions.

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.

MT ONE with 532/1064 nm Nd:YAG Q-Switch Laser Handpiece is indicated for:

0 Benign vascular and pigmented lesions, age spots
0 Nevus spilus
o Tattoo removal

MT ONE with fractional non-ablative 1540 nm Er Glass Laser Handpiece is indicated for

Post-operative Scars, Acne Scars, Skin Resurfacing, Striae 0

Comparison of Technological Characteristics:

MT ONE has the same technological characteristics (energy source, control mechanisms) and specifications as its predicate devices.

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K192856 MT ONE

(11)

medical technology

Specifications	HR635-950 nm Intense Pulse Light IN-MOVING
	Predicate device	Device object of 510(k)	Comparison to Predicate
Device Name(K number)	OMNIMAX S4K111303	MT ONEK192856
Wavelength	535-950 nm	635-950 nm	Equivalent to predicate device
Fluence	$0.5 - 25 J/cm^2$	$5 - 8 J/cm^2$	Equivalent to predicate device
Pulse duration	10 to 25 ms	6 ms	Equivalent to predicate device
Mode	Pulsed/burst	Pulsed/burst	Equivalent to predicate device
Repetition rate	0.4 to 1.25 Hz	0.4 to 1.25 Hz	Equivalent to predicate device
Spot size	6,4 cm²	6,4 cm²	Equivalent to predicate device
Intended use	Hair removal and permanent Hairreduction in all skin types (I-VI) to theFitzpatrick scale	Hair removal and permanent Hairreduction in all skin types (I-VI) to theFitzpatrick scale	Equivalent to predicate devices
Specifications	Predicate device	VLPL535-950 nm Intense Pulse Light with S.M.T.Device object of 510(k)	Comparison to Predicate
Device Name(K number)	ELLIPSE NORDLYSK150907FRAX 1550 FOR ELLIPSE NORDLYSK161162	MT ONEK192856
Wavelength	400-950 nm	535-950 nm	Equivalent to predicate device
Fluence	2-26 J/cm²	0.5 - 25 J/cm²	Equivalent to predicate device
Pulse duration	0.5 to 99,5 ms	0.5 to 99 ms	Equivalent to predicate device
Spot size	90 mm²	6,4 cm²	Equivalent to predicate device
Intended use	Treatment of TelangiectasiasTreatment of Port Wine StainsTreatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (eg Diffuse Redness)Treatment of RosaceaTreatment of Poikiloderma of CivatteTreatment of Inflammatory Acne Vulgaris	erythematous rosacea,Telangiectasias, PWS (Port Wine Stains) Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular lesion(eg Diffuse Redness)	Equivalent to predicate device

5-4

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K192856 MT ONE

(TIST)

medical technology

Device Name (K number)	Wavelength	Fluence	Spot size (round)	Pulse duration	Repetition rate	Intended use
							Nd:YAG Q-S Laser 532/1064 nm
							Predicate devices
HARMONY XLK072564	532 (KTP)/1064 nm		1/2/3/4/5/6 mm2.3 mm (KTP)	20 ns		Non-invasive removal of various colored tattoos, as well as deep and superficial benign pigmented lesions	Equivalent to predicate devices
M22K142860	1064 nm	0.9 to 14 J/cm²	2/2.5/3.5/4/5/6/8 mm	6 to 8 ns	0.5 to 5 Hz	Pigmented lesions and tatoo removal	Equivalent to predicate devices
OMNIMAX S4K111303	532/1064 nm	Up to 0.8 J/cm²	2/4/6 mm	10 ns	Up to 3 Hz smooth	Pigmented lesions and tatoo removal.	Equivalent to predicate devices
							Device object of 510(k)
MT ONEK192856	532/1064 nm	3,2 J/cm²(532 nm) φ8 mm4 J/cm²(1064 nm) φ8 mm	1, 2, 3, 4, 5, 8 mm	15 ns	Up to 10 Hz	Benign vascular and pigmented lesions, age spots and Nevus spilus, Tattoo removal	Equivalent to predicate devices

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K192856 MT ONE

(TIST)

medical technology

Device Name(K number)	Wavelength	Fluence(milliJoule per microbeam	Energy	Spot size (round)	Pulse duration	Inteded use	Device object of 510(k)
ICONK110907	1540 nm	40 – 70 mJ/mB		10, 15 mmXDmicrolens	10-15 ms	Wrinkles, surgical scars,stretch marks, skinresurfacing and soft tissuecoagulation	Equivalent to predicatedevices
ELLIPSE NORDLYSK150907FRAX 1550 FOR ELLIPSENORDLYSK161162	1550 nm	70 mJ/mB (tip 100)24 mJ/mB (tip 100)	5 – 100 mJ	4-12 mm	1-20 ms	The Frax 1550 Laser (1550nm) is indicated for use indermatological proceduresrequiring the coagulationof soft tissue, as well as forskin resurfacing procedures	Equivalent to predicatedevices
	1540 nm		7.7 J	10x10 mm square:Microscopic ThreatmentZones density 100;10x10 mm squareMicroscopic ThreatmentZonesdensity 324	10-15 ms	Post-operative Scars, AcneScars, Skin Resurfacing,Striae,	MT ONEK192856Equivalent to predicatedevices

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Image /page/10/Picture/0 description: The image shows the logo for M & T srl medical technology. The logo features a gray circle with the letters "m" and "t" inside. Below the circle, the text "M & T srl medical technology" is written in a simple, sans-serif font. The logo is clean and professional, suggesting a company that is focused on medical technology.

Performance data:

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

Biocompatibility testing

Materials in contact with patient skin, for a duration less than 24 hourss, were evaluated according to the "biocompatibility flow chart for the selection of toxicity tests for 510(k)s", attachment C of "Criteria of Use of International Standard ISO 10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing' (blue book memo)".

Safety and electromagnetic compatibility (EMC)

Electrical safety and EMC testing were conducted on the MT ONE device.

The system complies with the IEC 60601-2-22, IEC 60601-2-57 standards for safety and the IEC 60601-1-2 standard for EMC.

Software Verification and Validation Testing

Software verification and validation testing were conducted, and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices".

Comparison of Intended Use:

MT ONE device's Intended Use is the same Intended Use of its predicate device.

Conclusions:

MT ONE device has the same intended use and same technological characteristics and specification as its predicate devices.

Moreover, MT ONE has been tested in accordance to consensus standard to demonstrate safety.

MT ONE device is as safe and effective as its predicate devices.

Thus, MT ONE device is substantially equivalent to its predicate 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.