(87 days)
Not Found
No
The description mentions a "microprocessor based system controller" and "Software Verification and Validation Testing," which are standard for medical devices and do not indicate the presence of AI/ML. There is no mention of AI, ML, deep learning, or related concepts.
Yes
The device is indicated for hair removal and permanent hair reduction, which are medical treatments for a physical condition (hair growth). It is also used in "selective treatments required in the medical of dermatology and general and plastic surgery". These uses classify it as a therapeutic device.
No
The device is described as a laser emitting device for aesthetic, surgical, cosmetic, and hair removal applications. Its stated uses are for treatment, not for diagnosing conditions.
No
The device description explicitly states it is a "laser emitting device" comprising a "main console unit and a handpiece," which are hardware components. The software is described as a "microprocessor based system controller" and "graphic user interface" that monitors and directs system functions, indicating it is software within a hardware device, not a standalone software-only device.
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 "selective treatments required in the medical of dermatology and general and plastic surgery," specifically mentioning "hair removal and permanent hair reduction." These are all procedures performed on the body, not on samples taken from the body.
- Device Description: The description details a laser emitting device that operates with a handpiece in contact with the skin. This is consistent with a device used for external treatments.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any other components typically associated with in vitro diagnostics.
IVD devices are designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to apply energy to the skin for therapeutic or cosmetic purposes.
N/A
Intended Use / Indications for 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.
Product codes (comma separated list FDA assigned to the subject device)
GEX
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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)
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".
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.
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
§ 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 acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
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.
1
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
2
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)
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 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."
3
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/
Manufacturer
Name and Address: | M&T S.R.L.
Via Pietrarubbia 32/F
Rimini — 47900
Italy |
|-------------------------------------------------|----------------------------------------------------------------------------------------|
| 510(k) Contact Person: | Simonetta Strologo
Consultant |
| | Email: s.strologo@endoengineering.it
Phone: +39-071-9156048
Fax: +39-071-0971883 |
| Date Prepared: | 16/04/2019 |
| Device Name: | MT ONE DIAMOND |
| 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 |
| Predicate Devices: | Quanta Forte - QUANTA SYSTEM SPA - K152714
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.
4
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