MT One

K192856 · M&T S.R.L. · GEX · Apr 24, 2020 · General, Plastic Surgery

Device Facts

• Record ID: K192856
• Device Name: MT One
• Applicant: M&T S.R.L.
• Product Code: GEX · General, Plastic Surgery
• Decision Date: Apr 24, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4810
• Device Class: Class 2
• Attributes: Therapeutic

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 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 Story

MT ONE is a multi-application laser and Intense Pulsed Light (IPL) system for dermatological and surgical use. The device consists of a main console and various interchangeable handpieces (laser diode, IPL, Er:YAG, Nd:YAG, Er:Glass). The system is operated by a clinician in a clinical setting; handpieces are triggered via footswitch or finger switch. A microprocessor-based controller manages system functions and the graphic user interface. The device delivers light energy to target tissues (e.g., melanin in hair follicles, vascular structures, or skin surface for resurfacing). Clinical benefits include hair reduction, lesion removal, and skin rejuvenation. The provider uses the interface to select parameters based on the specific handpiece and treatment goal. The device is an expansion of the previously cleared MT One (K172413) platform, adding four new handpieces.

Clinical Evidence

No clinical data provided. Substantial equivalence is supported by bench testing, including biocompatibility evaluation per ISO 10993, electrical safety and EMC testing per IEC 60601-1-2, IEC 60601-2-22, and IEC 60601-2-57, and software verification and validation.

Technological Characteristics

Multi-modality system (Laser/IPL). Energy sources: Laser diodes, IPL lamps, Er:YAG, Nd:YAG, Er:Glass. Control: Microprocessor-based system controller. Connectivity: Standalone console. Patient-contact materials evaluated per ISO 10993. Safety standards: IEC 60601-1-2 (EMC), IEC 60601-2-22, IEC 60601-2-57.

Indications for Use

Indicated for aesthetic, surgical, and cosmetic applications in dermatology, general, and plastic surgery. Treats benign vascular/pigmented lesions, inflammatory acne (skin types I-V), erythematous rosacea, telangiectasias, PWS, warts, scars, striae, wrinkles, and unwanted hair (permanent reduction, skin types I-VI).

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

• Icon - PALOMAR - K110907
• Quanta Forte - QUANTA SYSTEM SPA - K152714
• OmniMax S4- SHARPLIGHT TECHNOLOGIES LTD. - K111303
• Harmony XI - ALMA LASERS LTD. - K072564
• M22 - LUMENIS LTD. - K142860
• MT One- M&T SRL - K172413
• ELLIPSE NORDLYS - K150907
• FRAX 1550 FOR NORDLYS- ELLIPSE A/S - K161162

Submission Summary (Full Text)

{0}------------------------------------------------

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 ([e-mail]) or phone [phone] 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

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K192856

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 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

{3}------------------------------------------------

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.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{4}------------------------------------------------

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.<br>Via Pietrarubbia 32/F<br>Rimini - 47900<br>Italy |
|------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Fiorenzo Rossi<br>CEO |
| | Email: [e-mail]<br>Phone: [phone] |
| 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 plastic<br>surgery and in dermatology |
| Regulation number: | 21 CFR 878.4810 |
| Classification product code: | GEX, ONG, ONF, ONE |
| Predicate Devices: | Icon - PALOMAR - K110907<br>Quanta Forte - QUANTA SYSTEM SPA - K152714<br>OmniMax S4- SHARPLIGHT TECHNOLOGIES LTD. - K111303<br>Harmony XI - ALMA LASERS LTD. - K072564<br>M22 - LUMENIS LTD. - K142860<br>MT One- M&T SRL - K172413<br>K150907 ELLIPSE NORDLYS + K161162 ELLIPSE FRAX 1550<br>FOR NORDLYS- ELLIPSE A/S |

{5}------------------------------------------------

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 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 erythematous rosacea, Telangiectasias, PWS (Port Wine Stains) Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular lesion(eg Diffuse Redness).

{6}------------------------------------------------

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 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 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.

{7}------------------------------------------------

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<br>(K number) | OMNIMAX S4<br>K111303 | MT ONE<br>K192856 | |
| 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 Hair<br>reduction in all skin types (I-VI) to the<br>Fitzpatrick scale | Hair removal and permanent Hair<br>reduction in all skin types (I-VI) to the<br>Fitzpatrick scale | Equivalent to predicate devices |
| Specifications | Predicate device | VLPL535-950 nm Intense Pulse Light with S.M.T.<br>Device object of 510(k) | Comparison to Predicate |
| Device Name<br>(K number) | ELLIPSE NORDLYS<br>K150907<br>FRAX 1550 FOR ELLIPSE NORDLYS<br>K161162 | MT ONE<br>K192856 | |
| 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 Telangiectasias<br>Treatment of Port Wine Stains<br>Treatment of Benign Pigmented Lesions (eg Mottled Pigmentation, Ephilides) and Benign Vascular Lesions (eg Diffuse Redness)<br>Treatment of Rosacea<br>Treatment of Poikiloderma of Civatte<br>Treatment of Inflammatory Acne Vulgaris | erythematous rosacea,<br>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

{8}------------------------------------------------

K192856 MT ONE

(TIST)

medical technology

ll

| Specifications | 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 XL<br>K072564 | 532 (KTP)/1064 nm | | 1/2/3/4/5/6 mm<br>2.3 mm (KTP) | 20 ns | | Non-invasive removal of various colored tattoos, as well as deep and superficial benign pigmented lesions | Equivalent to predicate devices |
| | M22<br>K142860 | 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 S4<br>K111303 | 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 ONE<br>K192856 | 532/1064 nm | 3,2 J/cm²(532 nm) φ8 mm<br>4 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 |

{9}------------------------------------------------

K192856 MT ONE

(TIST)

medical technology

I

| Specifications | Device Name<br>(K number) | Predicate devices | Wavelength | Fluence<br>(milliJoule per microbeam | Energy | Spot size (round) | Pulse duration | Inteded use | Device object of 510(k) |
|----------------|---------------------------------------------------------------------------|-------------------|------------|------------------------------------------|------------|-----------------------------------------------------------------------------------------------------------------------------------|----------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------|
| | ICON<br>K110907 | | 1540 nm | 40 – 70 mJ/mB | | 10, 15 mm<br>XDmicrolens | 10-15 ms | Wrinkles, surgical scars,<br>stretch marks, skin<br>resurfacing and soft tissue<br>coagulation | Equivalent to predicate<br>devices |
| | ELLIPSE NORDLYS<br>K150907<br>FRAX 1550 FOR ELLIPSE<br>NORDLYS<br>K161162 | | 1550 nm | 70 mJ/mB (tip 100)<br>24 mJ/mB (tip 100) | 5 – 100 mJ | 4-12 mm | 1-20 ms | The Frax 1550 Laser (1550<br>nm) is indicated for use in<br>dermatological procedures<br>requiring the coagulation<br>of soft tissue, as well as for<br>skin resurfacing procedures | Equivalent to predicate<br>devices |
| | | | 1540 nm | | 7.7 J | 10x10 mm square:<br>Microscopic ThreatmentZ<br>ones density 100;<br>10x10 mm square<br>Microscopic ThreatmentZones<br>density 324 | 10-15 ms | Post-operative Scars, Acne<br>Scars, Skin Resurfacing,<br>Striae, | MT ONE<br>K192856<br>Equivalent to predicate<br>devices |

{10}------------------------------------------------

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.