Predicate Devices

K110907, K152714, K111303, K072564, K142860, K172413, K150907, K161162

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes a laser and IPL device with a microprocessor-based system controller for monitoring and directing system functions and the user interface. There is no mention of AI, ML, or any features that would suggest the use of such technologies for image processing, diagnosis, or treatment planning. The performance studies focus on safety, EMC, and standard software verification/validation.

Therapeutic

Yes.

The device is indicated for the treatment of various medical conditions, including benign vascular lesions, inflammatory acne, benign pigmented lesions, and scar revision, which are therapeutic applications.

Diagnostic

No

The device description and intended use indicate that the MT ONE is an Intense Pulsed Light (IPL) and laser emitting device used for aesthetic, surgical, and cosmetic applications, primarily focusing on treatment of various skin conditions and hair removal, rather than for diagnosing conditions.

SaMD (Software as a Medical Device)

No

The device is a hardware device that emits Intense Pulsed Light (IPL) and laser energy through various handpieces for aesthetic and medical treatments. While it contains software for control and user interface, it is fundamentally a physical energy-emitting device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states the device is for aesthetic, surgical, and cosmetic applications, and for treatments in medical specialties like dermatology and general/plastic surgery. These are all procedures performed directly on the patient's body.
Device Description: The device description details a system that emits light (IPL and laser) and is used in contact with the skin. This is consistent with a therapeutic or aesthetic device, not a diagnostic one.
Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, tissue) or to provide diagnostic information about a patient's condition. IVDs are specifically designed for testing samples outside of the body to diagnose diseases or conditions.

The device is a therapeutic and aesthetic medical device that uses light energy to treat various skin conditions and for hair removal.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for 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

Product codes (comma separated list FDA assigned to the subject device)

GEX, ONG, ONF, ONE

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

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Soft tissue (skin and cutaneous tissue)

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)

Biocompatibility testing: Materials in contact with patient skin, for a duration less than 24 hours, 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".

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.

K110907, K152714, K111303, K072564, K142860, K172413, K150907, K161162

Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).

Not Found

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.

Summary

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 (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

2

Indications for Use

510(k) Number (if known) K192856

Device Name MT ONE

Indications for Use (Describe)