MT One Diamond

K191942 · M&T S.R.L. · GEX · Oct 17, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K191942
• Device Name: MT One Diamond
• Applicant: M&T S.R.L.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Oct 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

MT ONE DIAMOND and its handpiece is indicated 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 DIAMOND with HR808 nm laser handpiece is indicated for hair removal and permanent hair reduction. 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 Story

MT ONE DIAMOND is a laser-emitting device for aesthetic and surgical applications. System comprises a main console and a contact-type handpiece (HR808 nm laser diode). Operated by a clinician via footswitch or finger switch. A microprocessor-based controller manages system functions and the graphic user interface. Device is used in clinical settings for hair removal and permanent hair reduction. Output is laser energy delivered to the skin; clinical benefit is long-term stable reduction in hair count.

Clinical Evidence

Bench testing only. Evidence includes electrical safety and electromagnetic compatibility (EMC) testing per IEC 60601-2-22 and IEC 60601-1-2, and software verification and validation testing per FDA guidance.

Technological Characteristics

Laser-emitting device; HR808 nm laser diode handpiece; microprocessor-based system controller; contact-type handpiece; footswitch/finger switch activation; graphic user interface; electrical safety per IEC 60601-2-22; EMC per IEC 60601-1-2.

Indications for Use

Indicated for aesthetic, surgical, and cosmetic applications in dermatology, general, and plastic surgery. Includes hair removal and permanent hair reduction using HR808 nm laser handpiece.

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

• Quanta Forte - QUANTA SYSTEM SPA (K152714)
• MT One - M&T SRL (K172413)

Submission Summary (Full Text)

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October 17, 2019

M&T Srl % Simonetta Strologo Consultant Endo Engineering Srl Via Del Consorzio, 41 Falconara Marittaima, 60015 It

Re: K191942

Trade/Device Name: MT One Diamond 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: June 13, 2019 Received: July 22, 2019

Dear Simonetta Strologo:

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.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about 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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Purva Pandya 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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

## Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.

510(k) Number (if known)

K191942 Device Name MT ONE DIAMOND

Indications for Use (Describe)

MT ONE DIAMOND AND ITS HANDPIECE IS INDICATED 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 DIAMOND WITH HR808 NM LASER HANDPIECE IS INDICATED FOR HAIR REMOVAL AND PERMANENT HAIR REDUCTION.

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)

> Prescription Use (Part 21 CFR 801 Subpart D)

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

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Image /page/3/Picture/1 description: The image contains a logo and some text. The logo is a circle with the letters "m" and "t" inside. Below the logo, the text "M & T srl medical technology" is written. The text appears to be the name of a company or organization.

# 510(k) Summary

#### Introduction:

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

| Applicant/<br>Manufacturer<br>Name and Address: | M&T S.R.L.<br>Via Pietrarubbia 32/F<br>Rimini — 47900<br>Italy |
|-------------------------------------------------|----------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Simonetta Strologo<br>Consultant |
| | Email: [e-mail]<br>Phone: [phone]<br>Fax: [phone] |
| Date Prepared: | 16/04/2019 |
| Device Name: | MT ONE DIAMOND |
| Classification: | Class II |
| Classification Name: | Laser surgical instrument for use in general and plastic<br>surgery |
| Regulation number: | 21 CFR 878.4810 |
| Classification product code: | GEX |
| Predicate Devices: | Quanta Forte - QUANTA SYSTEM SPA - K152714<br>MT One - M&T SRL - K172413 |

#### Description of the device:

MT ONE DIAMOND is a laser emitting device that is operated with handpiece in contact with the skin.

MT ONE DIAMOND comprises a main console unit and a handpiece that is 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 handpiece:

- -HR808 nm Laser diode.

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Image /page/4/Picture/0 description: The image shows a logo with the letters 'm' and 't' intertwined. Below the logo, the text 'M & T srl medical technology' is written. The logo and text appear to be for a medical technology company called M & T srl.

#### Intended Use:

MT ONE DIAMOND and its handpiece is indicated 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 DIAMOND with HR808 nm laser handpiece is indicated for hair removal and permanent hair reduction.

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 DIAMOND 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)

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

The system complies with the IEC 60601-2-22 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 DIAMOND device's Intended Use is the same Intended Use of its predicate device.

#### Substantial Equivalence:

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

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

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