(57 days)
No
The document describes a microprocessor-based system controller for managing device functions and the user interface, but there is no mention of AI or ML capabilities for image processing, data analysis, or treatment optimization. The performance studies focus on safety, EMC, and software verification/validation, not AI/ML performance metrics.
Yes
The device is indicated for treatment of various medical conditions such as benign vascular lesions, inflammatory acne, warts, scars, and revision of acne scars, which are therapeutic applications.
No
The MT ONE is described as an Intense Pulsed Light (IPL) and laser emitting device intended for various aesthetic, surgical, and cosmetic treatments, and for selective treatments in dermatology and general and plastic surgery. Its listed indications for use are focused on treatment of conditions (e.g., vascular lesions, pigmented lesions, hair removal, acne, wrinkles, scars), not on diagnosing them.
No
The device description clearly states it is an Intense Pulsed Light (IPL) and laser emitting device comprising a main console unit and several handpieces, which are hardware components. While it includes a microprocessor-based system controller and software verification/validation, it is not solely software.
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 in selective treatments required in the medical of dermatology and general and plastic surgery." It describes various treatments performed on the patient's body (skin and cutaneous tissue) using light and laser energy.
- Device Description: The device description confirms it's an "Intense Pulsed Light (IPL) and laser emitting device that is operated with handpiece in contact with the skin." This is a therapeutic device that interacts directly with the patient's body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue samples) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of biological specimens.
The device described is a therapeutic medical device used for various dermatological and cosmetic procedures.
N/A
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 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.
Product codes
GEX, ONF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Skin and cutaneous tissue (for Er-Yag2940USnm Laser Handpiece); Hair follicles (for Nd:YAG1064(LP)USnm Laser Handpiece)
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
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".
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
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):
1
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
2
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 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.
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.
3
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 PRAStaff@fda.hhs.gov
"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
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;
5
- -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).
6
*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.