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

MT ONE with HR808USnm Laser Handpiece is indicated for treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.

MT ONE with AC415-950USnm 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 VLPL535-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contact-cooling) is indicated for the treatment of Benign Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick Scale.

MMT ONE with HR580-950USnm 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.

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

MMT ONE with HR635-950USnm 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 Er-Yag2940USnm 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 Nd:YAG1064(LP)USnm 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 or without adjuvant preparation);
Treatment of pseudofolliculitis barbae (PEB).

*Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime.

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.

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:

HR808USnm Laser diode;
AC415-950USnm intense Pulsed Light;
VLPL535-950USnm Intense Pulsed Light;
HR580-950USnm Intense Pulsed Light;
SR580-950USnm Intense Pulsed Light;
HR635-950USnm Intense Pulsed Light;
Er-Yag Laser 2940 nm;
Nd:Yag LP Laser 1064 nm.

AI/ML Overview

This FDA 510(k) summary for the MT ONE device, a laser and IPL system for aesthetic and surgical applications, does not provide the level of detail typically found in a study demonstrating acceptance criteria for AI/ML-driven devices. This document describes a traditional medical device and its equivalence to predicate devices, rather than an AI/ML algorithm.

Therefore, many of the requested fields cannot be filled as they pertain to algorithm performance evaluation, which is not present in this document.

Here's an analysis based on the provided text, highlighting what can be extracted and what cannot:

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

Acceptance Criteria Category	Reported Device Performance (as per document)
Safety and Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1, IEC 60601-2-22, IEC 60601-2-57 (safety) and IEC 60601-1-2 (EMC).
Software Verification and Validation	Conducted and documentation 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".
Technological Characteristics	"MT ONE has the same technological characteristics (energy source, laser/IPL source, control mechanisms) and specifications as its predicate devices."
Intended Use	"MT ONE device's Intended Use is the same Intended Use of its predicate device."

Study Details (as per request, with limitations due to device type):

The document describes the device as being "substantially equivalent" to predicate devices, rather than a clinical study establishing new performance metrics. The "performance data" section focuses on regulatory compliance and comparison to predicates, not specific clinical outcome metrics.

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

Not applicable for this document. This document focuses on the device (a laser/IPL system) and its regulatory compliance and equivalence to predicate devices, not on the performance of a specific algorithm on a test set of data.

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)

Not applicable. There is no mention of a test set requiring expert-established ground truth for an algorithm.

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

Not applicable. No test set or expert adjudication process is described for an algorithm.

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 document is for a physical medical device (laser/IPL system), not an AI-driven diagnostic or assistive tool for human readers.

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

Not applicable. This is not an algorithm-only device.

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

Not applicable. The "ground truth" conceptually in this submission is the established safety and effectiveness of the predicate devices and the physical testing of the MT ONE device against relevant international standards (e.g., IEC 60601 series).

8. The sample size for the training set

Not applicable. No training set for an algorithm is mentioned.

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

Not applicable. No training set for an algorithm is mentioned.

Summary of what is present:

The document serves as a 510(k) summary for a medical device (MT ONE) that is a laser and Intense Pulsed Light (IPL) emitting system. The acceptance criteria and "proof" of meeting those criteria are framed in terms of:

Compliance with recognized electrical safety and EMC standards (IEC 60601 series).
Software verification and validation according to FDA guidance.
Substantial equivalence to previously cleared predicate devices in terms of intended use and technological characteristics (energy source, laser/IPL source, control mechanisms, specifications).

The document's purpose is to demonstrate that the MT ONE device is as safe and effective as existing legally marketed predicate devices, not to establish novel performance metrics for a new AI/ML algorithm.

Summary

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Image /page/0/Picture/0 description: The image contains 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" and "ADMINISTRATION" in blue text.

October 6, 2017 M&T S.R.L % Chiara Violini Endo Engineering S.r.l. via Del Consorzio, 41 Falconara Marittima, Ancona, Italy 60015

Re: K172413 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, ONF Dated: July 31, 2017 Received: August 10, 2017

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. 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 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); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820):

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely, Jennifer R. Stevenson -S3 For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K172413

Device Name MT ONE

Indications for Use (Describe)

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

MT ONE with HR808USnm Laser Handpiece is indicated for treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.

MT ONE with Er-Yag2940USnm 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 Nd:YAG1064(LP)USnm 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 or without adjuvant preparation);
Treatment of pseudofolliculitis barbae (PEB).

*Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime.

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

X 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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ഗ 510(k) Summary

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/	M&T S.R.L.
Manufacturer
Name and Address:	Via Pietrarubbia 32/F
	Rimini - 47900
	Italy
510(k) Contact Person:	Chiara Violini
	Consultant
	Email: c.violini@endoengineering.it
	Phone: +39-071-9156048
	Fax: +39-071-0971883
Date Prepared:	03/10/2017
Device Name:	MT ONE
Classification:	Class II
Classification Name:	Laser surgical instrument for use in general and plastic surgery
Regulation number:	21 CFR 878.4810
Classification product code:	GEX, ONF
Predicate Devices:	Quanta Forte QUANTA SYSTEM SPA K152714
	OMNIMAX S Sharplight Technologies Ltd K111303

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.

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:

। HR808USnm Laser diode;

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-AC415-950USnm intense Pulsed Light;
-VLPL535-950USnm Intense Pulsed Light;
-HR580-950USnm Intense Pulsed Light;
-SR580-950USnm Intense Pulsed Light;
-HR635-950USnm Intense Pulsed Light;
-Er-Yag Laser 2940 nm;
-Nd:Yag LP Laser 1064 nm.

Intended Use:

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

MT ONE with HR808USnm Laser Handpiece is indicated for treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction*.

MT ONE with AC415-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contactcooling) is indicated for the treatment of Infiammatory Acne vulgaris) in skin types (I-V) to the Fitzpatrick Scale.

MT ONE with VLPL535-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contactcooling) is indicated for the treatment of benign Pigmented and Vascular Lesions in all skin types (I-VI) to the Fitzpatrick Scale.

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

MT ONE with SR580-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contactcooling) is indicated for the 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 HR635-950USnm Intense Pulsed Light (IPL) Handpiece (with and without contactcooling) is indicated for the hair removal and permanent hair reduction* in all skin types (I-VI) to the Fitzpatrick Scale.

MT ONE with Er-Yag2940USnm 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; Keratoses; Scar revision (including acne scars).

MT ONE with Nd:YAG1064(LP)USnm 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 or without adjuvant preparation);
-Treatment of pseudofolliculitis barbae (PEB).

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*Permanent hair reduction is defined as the long term, stable reductions in the number of hairs when measured at 6, 9 and 12 months after the completion of a treatment regime.

Comparison of Technological Characteristics:

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

Performance data:

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

Safety and electromagnetic compatibility (EMC)

The system complies with the IEC 60601-1, 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.

Conclusion:

MT ONE device has the same intended use and same technological characteristics and specification 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.