WARNING LETTER
Mectronic Medicale S.R.L.
MARCS-CMS 707997 —
June 27, 2025
Product:
Medical Devices
Recipient:
Recipient Name
Ennio Aloisini
Recipient Title
Chief Executive Officer
Mectronic Medicale S.R.L.
Via Orio Al Serio 15
24050
BG
Italy
(b)(4)@mecmedix.com
Issuing Office:
Center for Devices and Radiological Health
United States
WARNING LETTER
CMS # 707997
June 27, 2025
Dear Mr. Aloisini:
During an inspection of your firm located in Bergamo, Italy from February 24, 2025, through February 27, 2025, an investigator from the United States Food and Drug Administration (FDA, we, or the agency) determined that your firm manufactures CHELT, Ixyon XP, iLux Smart, iLux Plus, Doctor Tecar, Doctor Tecar Smart, and Doctor Tecar Plus devices. Under section 201(h) of the Federal Food, Drug, and Cosmetic Act (the Act), 21 U.S.C. § 321(h), these products are devices because they are intended for use in the diagnosis of disease or other conditions or in the cure, mitigation, treatment, or prevention of disease, or to affect the structure or function of the body. In addition, under section 531(2) of the Act, 21 U.S.C. § 360hh(2), each of these products is an electronic product because it is (A) a manufactured or assembled product which, when in operation, (i) contains or acts as part of an electronic circuit and (ii) emits (or in the absence of effective shielding or other controls would emit) electronic product radiation, or (B) a manufactured or assembled article which is intended for use as a component, part, or accessory of a product described in clause (A) and which when in operation emits (or in the absence of effective shielding or other controls would emit) such radiation.
Quality System Regulation Violation(s)
This inspection revealed that these devices are adulterated within the meaning of section 501(h) of the Act, 21 U.S.C. § 351(h), in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements of the Quality System regulation found at Title 21, Code of Federal Regulations (CFR), Part 820. These violations include, but are not limited to, the following:
1. Failure to establish and maintain a DHF for each type of device, as required by 21 CFR 820.30(j).
For example: Your firm’s design control procedures, PO_7.3_Design and Development, state the design elements requirements of the quality system regulation (i.e., Design and Development Planning, Design Input, Design Output, Design Verification, Design Validation, Design Transfer, and Design Changes) and that these design elements should be documented. However, a review of your firm’s therapeutic RF, laser, and laser/cryotherapy family Design History Files (DHF) demonstrated that your firm did not adequately document any of these design elements required per 21 CFR 820.30 Design Controls. For example, the three reviewed DHFs documented short statements or phrases of what occurred during each phase, but your firm failed to document any objective evidence of the activities conducted during all design phases for the three product families.
2. Failure to ensure that where the results of a process cannot be fully verified by subsequent inspection and test, the process shall be validated with a high degree of assurance and approved according to established procedures, as required by 21 CFR 820.75(a).
For example: Your firm has stated that it has not established process validation where the results of a process cannot be fully verified by subsequent inspection and test. For example, your firm has not validated your output calibration system based on an established procedure. Your firm stated that you have not established process validation and/or test method validation procedures for your output calibration system, consisting of an
(b)(4)
and
(b)(4)
, used in the production of your therapeutic RF emitting device. Additionally, your firm did not have any records of performing validation of the system
3. Failure to establish and maintain procedures to control product that does not conform to specified requirements, as required by 21 CFR 820.90.
For example: Your firm did not properly identify and segregate nonconforming products. Your firm’s procedure, PO_8.3_Nonconformity Management, states that defective parts should be identified by means of red sticker, NCM identification code, and product is to be segregated in the area designated for nonconformities. However, during the inspection component was found outside of designated quarantine areas and nonconforming product was found lacking a red sticker and identification code.
Additionally, a production record for a Doctor Tecar RF therapeutic device, serial number DT07222, was reviewed during the inspection. The record indicated that the product was nonconforming as it failed to meet the peak-to-peak voltage (Vpp) output specification for one of the frequency/power combinations during device acceptance. However, your firm failed to identify this device as nonconforming and the product was released without justification or assessment.
4. Failure to establish and maintain procedures acceptance activities, as required by 21 CFR 820.80.
For example: During the inspection your firm was unable to provide procedures for receiving inspection and stated that receiving inspection procedures have not been established. For example, your firm stated that they performed a 100% verification of laser diode power output and identified these as critical components used in your firm’s therapeutic devices. However, the laser diode acceptance activities were recorded on an uncontrolled document without identifying the test equipment used (e.g., laser power meter), nor its operator performing the test. These were not recorded in your firm’s Device History Record.
5. Failure to establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as required by 21 CFR 820.198(a).
For example: During the inspection, your firm’s management stated that they could not provide any specific complaint records because none had been documented to date. Your firm’s procedure, PO_8.2.1_Return Information section 8.2, requires complaints to be documented on the form, MOD_8.3a_NC and AC/AP. The form is also used in the assessment of the complaints to determine the need to open and manage a corrective action. Your firm provided a complaint log which listed 22 complaints that your firm received. However, your firm was not able to provide evidence that these complaints were reviewed and evaluated by a formally designated unit.
6. Failure to establish and maintain instructions and procedures for performing and verifying that the servicing meets the specified requirements, as required by 21 CFR 820.200.
For example: Your firm’s servicing procedures, PO_7.5a_Production and delivery of services, section 6.7, generally describe your firm’s service products and generates a corresponding service record for all of your firm’s products. However, the procedures do not contain any specific information about how to perform routine servicing activities, acceptance testing following servicing, nor documentation requirements. Additionally, your firm provided a service record for a Doctor Tecar Plus device, serial# DTP07522, and it did not document the UDI of the service device. Furthermore,
(b)(4)
quantitative acceptance points were only recorded as two check marks on a separate uncontrolled document.
7. Failure to establish procedures for identifying training needs and ensure that all personal are trained to adequately perform their assigned responsibilities, as required by 21 CFR 820.25(b).
For example: Your firm’s procedure, PO_6.2_Training, requires management to define the training needs of employees on Form 6.2.3a Training Planning and for the identified internal training to be documented. However, your firm could not provide your training plan and training records for your production employees.
8. Failure to maintain device history records as required by 21 CFR 820.184.
For example: Your firm failed to document a copy of the primary product labeling for the Doctor Tecar device in each instance based on the inspection for 10 DHRs. This includes the handpiece label with a corresponding serial number and unit/console label with a corresponding serial number and UDI.
9. Failure to establish procedures for quality audits and conduct such audits to assure that the quality system is in compliance with the established quality system requirements and to determine the effectiveness of the quality system, as required by 21 CFR 820.22.
For example: Your firm’s procedures, for internal audits, P O _8.2.4_Inspection Visits, require that internal auditors to not have direct responsibility in the areas they audit to ensure that the auditors are independent. However, your firm’s Administrative, Financial, & Quality Manager audited the quality system areas that they have direct responsibility over. For example, the Administrative, Financial & Quality Manager audited:
CY2025 Internal audit plan – Coverage of monitoring of products and processes (i.e. final device acceptance), CAPA and Non-conformances.
CY2024 Internal audit plan and completed internal audit record – Coverage of monitoring of products and processes (i.e. final device acceptance), CAPA and Non-conformances.
CY2023 Internal audit plan and completed internal audit record – Coverage of your firm’s entire quality management system.
Medical Device Reporting (MDR) Violation(s)
Our inspection revealed that your firm has failed to develop, maintain, and implement written Medical Device Reporting (MDR) procedures, as required by 21 CFR 803.17. Specifically, your firm has stated that it has not established any procedures for MDRs. These would include establishing procedures for timely and effective identification, communication, and evaluation of reportable events, a standardized review process for determining when an event meets reportability criteria, timely submission of MDRs to the FDA, and compliance with the applicable documentation and recordkeeping requirements.
A device is deemed to be misbranded under section 502(t)(2) of the Act, 21 U.S.C. § 352(t)(2), if there was a failure or refusal to furnish any material or information required by or under section 519 of the Act, 21 U.S.C. § 360i, which includes adverse event reports required under 21 CFR Part 803, respecting the device.
In response to this letter, please provide any completed actions taken by your firm to address this item or your planned actions and the timeframe for when these actions will be completed.
Unapproved Device Violation(s)
Our inspection also revealed that the devices are adulterated under section 501(f)(1)(B) of the Act, 21 U.S.C. § 351(f)(1)(B), because your firm does not have an approved application for premarket approval (PMA) in effect pursuant to section 515(a) of the Act, 21 U.S.C. § 360e(a), or an approved application for an investigational device exemption (IDE) under section 520(g) of the Act, 21 U.S.C. § 360j(g) for the device as described and marketed. These devices are also misbranded under section 502(o) the Act, 21 U.S.C. § 352(o), because your firm did not notify the agency of its intent to introduce the device into commercial distribution, intended for a use different from the intended use of a legally marketed device, without submitting a premarket notification to FDA as required by section 510(k) of the Act, 21 U.S.C. § 360(k).
1. Your Doctor Tecar, Doctor Tecar Smart, and Doctor Tecar Plus devices have been cleared for the following indications:
K221043 – Doctor Tecar Plus and Doctor Tecar Smart devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.
K183693 – The Doctor Tecar device is intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as relief of pain, muscle spasms, and increase in local circulation.
However, you are marketing these devices without clearance for the following uses in your marketing materials, including but not limited to:
“Doctor Tecar Therapy is an innovative, high-performance therapy in the treatment of Carpal Tunnel Syndrome.”
“Doctor Tecar Therapy not only provides rapid pain relief, but also accelerates the healing process, significantly reducing recovery time and improving the effectiveness of treatments.”
“Accelerated Healing: Boosts cellular metabolism for faster and more effective rehabilitation.”
These statements were not reviewed as part of your premarket notification materials submitted to FDA and are outside of the scope of the clearances issued under K221043 and K183693. FDA is currently unaware of any evidence that could support the above intended uses. These statements appear to constitute changes in the intended use of the products that require submission of a new 510(k), as provided by 21 CFR 807.81(a)(3)(ii). These new intended uses raise effectiveness concerns that are different from those normally associated with the cleared uses of the device. These topical heating devices use energy to generate heat within layers of the skin and require performance testing for specific indications for use that presume a specific clinical outcome. The above-mentioned new treatment claims have not been evaluated in the 510(k) submissions and substantiated by supporting data for the new treatment claims such as any clinical data demonstrating the treatment of Carpal Tunnel Syndrome, reduced recovery time and boosting of cellular metabolism. Patients who use this device may forego other known therapies and delay addressing their health concerns that may result in serious injury or lengthen recovery times.
2. The FDA has reviewed the user manuals for the CHELT, iLux Plus, iLux Smart, and Ixyon XP devices, which your firm introduced or delivered for introduction these devices into interstate commerce for commercial distribution, and which you have listed in FDA’s registration and listing database as intended for use in the generic type of device described at 21 CFR 890.5500 (infrared lamp) and product code ILY (lamp, infrared, therapeutic heating). Devices regulated under 21 CFR 890.5500 and ILY are exempt from premarket notification unless they exceed the limitations of exemption described in 21 CFR 890.9(a). However, there is evidence that the CHELT, Ixyon XP, iLux Smart, and iLux Plus are intended for uses that are different from those of legally marketed devices regulated under 21 CFR 890.5500 and ILY.
Generic devices of this type emit energy at infrared frequencies (approximately 700 to 50,000 nanometers) to provide topical heating and are intended for medical purposes including, but not limited to, temporary increase in local blood circulation and temporary relief of: muscle spasms, minor joint pain and stiffness, minor muscle pain and stiffness, and minor arthritis pain. However, your firm is marketing the CHELT, Ixyon XP, iLux Smart, and iLux Plus for different specific intended uses, namely “f
or the treatment of pathologies of the musculoskeletal system such as lumbago, cervicalgia, epicondylitis, medial epicondylitis, . . . as well as contractures . . .
” FDA is currently unaware of any clinical evidence that could support these intended uses. These uses increase the risk of injury because of deeper tissue penetration, and potentially higher energy and temperature delivery to target structures not addressed in legally marketed ILY devices. The specific conditions including lumbago, cervicalgia, epicondylitis, medial epicondylitis, and contractures, involve anatomical sites that are more sensitive than superficial muscle groups. Treating these conditions with infrared heating or high-intensity laser therapy can result in overheating of deeper tissues, burns, nerve injury, or damage to underlying structures. Additionally, these new indications introduce uncertainty about safety and efficacy because there is no validated clinical evidence to support the benefits outweighing the risks for these specific treatment indications. These risks are not present in currently cleared or exempted ILY indications, which are limited to superficial, non-specific pain relief through mild, topical heating. The devices are therefore not exempt from the 510(k) requirement as described in 21 CFR 807.81(a)(3)(ii).
In addition, the CHELT, Ixyon XP, iLux Smart, and iLux Plus devices include a maximum threshold for a skin surface temperature of 50°C. A safe and effective therapeutic skin surface temperature range for infrared lamps is 40 - 45°C because skin surface temperatures greater than 45°C present a risk of skin burns in generic devices of this type. The 50°C maximum skin surface temperature threshold is a different technological characteristic for this generic device type. Because there is evidence that the CHELT, Ixyon XP, iLux Smart, and iLux Plus have different intended uses and technology compared with that of legally marketed devices classified under 21 CFR 890.5500, the devices exceed the limitations described in 21 CFR 890.9(b) and are not exempt from premarket notification requirements. They are also therefore subject to the requirement under 21 CFR 807.81(3)(a)(i).
For a device requiring premarket approval, the notification required by section 510(k) is deemed satisfied when a PMA is pending before the agency. [21 CFR 807.81(b)] The kind of information that your firm needs to submit in order to obtain approval or clearance for the device is described on the Internet at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/default.htm. The FDA will evaluate the information that your firm submits and decide whether the product may be legally marketed.
Electronic Product Radiation Control Device Violation(s)
Our inspection also revealed that your firm failed to comply with reporting requirements applicable to electronic products under 21 CFR Chapter I, Subchapter J – Radiological Health. Section 538(a) of the Act (21 U.S.C. 360oo(a)) prohibits, in part, any person to fail or refuse to make any report, or furnish or preserve any information required by section 537 of the Act (21 U.S.C. 360nn).
In addition to being a "device," Ixyon therapeutic laser family of devices are "electronic products" subject to compliance with Chapter V, Subchapter C of the Act, Electronic Product Radiation Control (21 U.S.C. 360hh et seq.) and the general requirements at 21 CFR Parts 1000-1005, including reporting requirements at 21 CFR Part 1002, which are prescribed pursuant to section 537 of the Act.
Significant violations include, but are not limited to, failure to submit a radiation safety product report followed by annual reports as required by 21 CFR 1002.10 and 1002.13, respectively. For example, during the inspection, Ms. Chiara (NMI) Borgonovo, Export Area Manager, clarified that Mectronic Medicale S.R.L. has shipped eight (8) laser devices to the US for sales purposes. A review of our records indicates that the required radiation safety report (21 CFR 1002.10) for your company’s Ixyon therapeutic laser family of devices has not been received by FDA. In addition, FDA has not received the required annual reports for the CHELT model of products (21 CFR 1002.13).
Manufacturers of laser products are responsible for assuring their products comply with all applicable mandatory federal radiation safety performance standards prior to entry of those products into US commerce. For medical lasers, the applicable performance standards are 21 CFR Part 1010, 1040.10, and 1040.11(a). Additionally, manufacturers of these products are subject to all applicable requirements of Title 21 CFR Parts 1000 – 1005, which includes the reporting and record keeping requirements found in Title 21 CFR Part 1002.
We also note that, while FDA has stated the agency does not intend to enforce the requirements of 21 CFR 1040.10 and 1040.11(a) if the laser products have incorporated the comparable clause of IEC 60825-1 Ed. 3 (see FDA’s Laser Notice 56 available here: https://www.fda.gov/media/110120/download), the applicable “DANGER” phrase (see IEC 60825-1 Ed. 3, clause 7.7) is missing from the warning logotype label as depicted in the user manuals of the Ixyon, iLux, and CHELT therapeutic laser family of devices.
Please revise your warning logotype labels for compliance with the applicable requirements outlined in 21 CFR 1040.10(g)(3), which FDA considers to be comparable to conformance with IEC 60825-1 Ed. 3, clause 7.7. Please submit the revised labels as part of your response to this correspondence.
For therapeutic laser devices that do not currently have a radiation safety report on file, please ensure that copies of compliant warning logotype labels are included in all future submissions.
Additionally, you should update your company’s quality control procedures to ensure that all future production units intended to enter the U.S. commerce bear the required warning logotype label. Copies of the labels must also be included in relevant promotional materials, such as the device user manual as required per 21 CFR 1040.10(h)(1)(iii).
Please also provide the following information: (a) list all models of laser products your firm manufactured and imported to the US, and (b) whether Mectronic Medicale S.R.L. certified each laser product which entered commerce as required by Title 21 CFR 1010.2. Please note that medical laser product certification according to 21 CFR 1010.2 and ISO 13485 certification are not the same. The FDA regulation (21 CFR 1010.2) specifically addresses laser product safety and performance standards in the U.S., while ISO 13485 is an international standard for quality management systems in medical device manufacturing. The FDA certification focuses on the product itself, whereas ISO 13485 covers broader organizational processes and quality management. While both are relevant for medical laser manufacturers, they serve distinct purposes in regulatory compliance and quality assurance.
Copies of the Federal Performance Standards, compliance guides, radiation safety product report guides, and other documents related to laser products are available on FDA’s web site at: http://www.fda.gov/Radiation-EmittingProducts/default.htm, and https://www.fda.gov/radiation-emitting-products/surgical-and-therapeutic-products/medical-lasers.
Please submit the missing radiation safety reports for all models that are already imported into the US, or that you plan to enter the US market. Please use Form FDA 3632 to prepare your radiation safety product reports, and form FDA 3636 for the annual report. All Radiation Safety reports and supporting materials can be submitted to the FDA by email at: RadHealthCustomerService@fda.hhs.gov.
Other federal agencies may take your compliance with the FD&C Act and its implementation regulations into account when considering the award of federal contracts. Additionally, should FDA determine that you have Quality System regulation violations that are reasonably related to premarket approval applications for Class III devices, such devices will not be approved until the violations have been addressed.
This letter notifies you of our findings and provides you an opportunity to correct the above deficiencies. Please notify this office in writing within fifteen business days from the date you receive this letter of the specific steps your firm has taken to address the noted violations, including an explanation of how your firm plans to prevent these violations, or similar violations, from occurring again. Include documentation of the corrections and/or corrective action (which must address systemic problems) that your firm has taken. If your firm’s planned corrections and/or corrective actions will occur over time, please include a timetable for implementation of those activities. If corrections and/or corrective actions cannot be completed within fifteen business days, state the reason for the delay and the time within which these activities will be completed.
Please provide a translation of documentation not in English to facilitate our review. We will notify you regarding the adequacy of your firm’s response and the need to re-inspect your firm’s facility to verify that the appropriate corrections and/or corrective actions have been made. If you believe that your products are not in violation of the FD&C Act, include your reasoning and any supporting information for our consideration as part of your response.
Your firm’s response should be sent via email to James Jang at CDRHEnforcement@fda.hhs.gov. Please include in the subject line, “CMS Case 707997” when replying. If you have any questions about the contents of this letter, please contact: Andrew Keys at Andrew.Keys@FDA.HHS.Gov
Finally, you should know that this letter is not intended to be an all-inclusive list of the violations at your firm’s facility or associated with your firm’s devices and electronic products. It is your firm’s responsibility to ensure compliance with applicable laws and regulations administered by FDA. The specific violations noted in this letter and in the Inspectional Observations, FDA 483, issued at the close of the inspection may be symptomatic of serious problems in your firm’s manufacturing and quality management systems. Your firm should investigate and determine the causes of any violations and take prompt actions to address any violations and bring the products into compliance.
Sincerely,
/S/
Bleta Vuniqi Houtkamp
Deputy Office Director
OHT4: Office of Surgical and Infection Control Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health
CC:
Jerry Doane
Pragmatic Compliance dba FDAbasics
15815 SW 11th Court Rd
Ocala, FL US 34473
Usagent@fdabasics.com
Content current as of:
08/05/2025
Regulated Product(s)
Medical Devices