← Product Code [OBP](/productcode/OBP) · K260560 # Apollo TMS Therapy System;Apollo light TMS Therapy System (K260560) _Mag & More GmbH · OBP · May 22, 2026 · Neurology · SESE_ **Canonical URL:** https://fda.innolitics.com/device/K260560 ## Device Facts - **Applicant:** Mag & More GmbH - **Product Code:** [OBP](/productcode/OBP.md) - **Decision Date:** May 22, 2026 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 882.5805 - **Device Class:** Class 2 - **Review Panel:** Neurology - **Attributes:** Therapeutic, Real-World Evidence ## Real-World Evidence | Submission | Device | Sponsor | RWD Sources | RWE Use Summary | Key Tags | | --- | --- | --- | --- | --- | --- | | K260560 · May 22, 2026 | Apollo TMS Therapy System;Apollo light TMS Therapy System | Mag & More GmbH | Retrospective medical chart reviews; Large-scale analysis of real-world data | The sponsor relies on clinical evidence previously cleared in K220127, which utilized retrospective observational studies and real-world data analysis to demonstrate the safety and effectiveness of the TMS treatment protocol for MDD and comorbid anxiety symptoms. | Retrospective chart review; Real-world data; MDD; Anxiety symptoms; Predicate device evidence | ### Clinical Evidence | Study Design | Population | Comparator | Key Endpoints | | --- | --- | --- | --- | | Clinical evidence from K220127; Observational studies (retrospective medical chart review) and large-scale analysis of real-world data | Adult patients suffering from Major Depressive Disorder (MDD) with comorbid anxiety symptoms | Not applicable for this study | Improvement in anxiety symptoms | ## Indications for Use The Apollo TMS Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. ## Device Story Electromagnetic device delivering rapidly pulsed magnetic fields to cerebral cortex; non-invasively activates neurons without inducing seizure. Components: main unit, stimulation coil, coil positioning system, user interface (Stimware software). Operator (clinician) uses Stimware to manage treatment protocols and determine individual stimulation dose based on motor threshold. Coil positioned to left dorsolateral prefrontal cortex (DLPFC). High-frequency rTMS increases cortical excitability. Used in clinical settings to treat MDD and comorbid anxiety; output affects clinical decision-making by providing non-pharmacological intervention for treatment-resistant patients. ## Clinical Evidence No new clinical data provided. Efficacy and safety for MDD and comorbid anxiety symptoms were established in K220127, which included two randomized controlled trials, an open-label study, and four observational studies (retrospective chart reviews), including a large-scale real-world data analysis. ## Technological Characteristics Electromagnetic rTMS system; figure-of-eight coil (pCool/aCool variants); biphasic waveform. Standards: ISO 10993-1 (biocompatibility), IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 60601-1-6 (usability), IEC 62304 (software). Coil positioning via landmark-aided system or 10-20-EEG cap. 10 Hz stimulation frequency; 120% motor threshold intensity. ## Regulatory Identification A repetitive transcranial magnetic stimulation system is an external device that delivers transcranial repetitive pulsed magnetic fields of sufficient magnitude to induce neural action potentials in the prefrontal cortex to treat the symptoms of major depressive disorder without inducing seizure in patients who have failed at least one antidepressant medication and are currently not on any antidepressant therapy. ## Special Controls *Classification.* Class II (special controls). The special control is FDA's “Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation System.” See § 882.1(e) for the availability of this guidance document. ## Predicate Devices - NeuroStar Advanced Therapy System ([K220127](/device/K220127.md)) - Apollo TMS Therapy System ([K180313](/device/K180313.md)) - Apollo TMS Therapy System ([K232639](/device/K232639.md)) - Apollo TMS Therapy System ([K243700](/device/K243700.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0} FDA U.S. FOOD & DRUG ADMINISTRATION May 22, 2026 Mag & More GmbH Juliane Rieß Regulatory Affairs Management Machtlfinger Straße 13 Munich, 81379 Germany Re: K260560 Trade/Device Name: Apollo TMS Therapy System; Apollo light TMS Therapy System Regulation Number: 21 CFR 882.5805 Regulation Name: Repetitive transcranial magnetic stimulation system Regulatory Class: Class II Product Code: OBP Dated: February 19, 2026 Received: February 19, 2026 Dear Juliane Rieß: 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 (the 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 available 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. Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K260560 - Juliane Rieß Page 2 (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download). Your device is also subject to, among other requirements, the Quality Management System Regulation (QMSR) (21 CFR Part 820), which includes, but is not limited to, ISO 13485 clause 7.3 (Design controls), ISO 13485 clause 8.3 (Nonconforming product), ISO 13485 clause 8.5.2 (Corrective action), and ISO 13485 clause 8.5.3 (Preventative action). Please note that regardless of whether a change requires premarket review, the QMSR requires device manufacturers to review and approve changes to device design and production (ISO 13485 clause 7.3 and ISO 13485 clause 7.5) and document changes and approvals in the Medical Device File (ISO 13485 clause 4.2.3). 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 (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the Quality Management System Regulation (QMSR) (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050. All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for {2} K260560 - Juliane Rieß Page 3 more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, ROBERT KANG -S for Pamela Scott Assistant Director DHT5B: Division of Neuromodulation and Physical Medicine Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health Enclosure {3} | Indications for Use | | | | --- | --- | --- | | Please type in the marketing application/submission number, if it is known. This textbox will be left blank for original applications/submissions. | K260560 | ? | | Please provide the device trade name(s). | | ? | | Apollo TMS Therapy System; Apollo light TMS Therapy System | | | | Please provide your Indications for Use below. | | ? | | The Apollo TMS Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. | | | | Please select the types of uses (select one or both, as applicable). | ☑ Prescription Use (21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) | ? | | Please select the age group(s) for which the device(s) is to be used. | ☐ Neonates/Newborns (Birth to < 29 days old) ☐ Infants (29 days old to < 2 years old) ☐ Children (2 years old to < 12 years old) ☐ Adolescents (12 years old to < 22 years old) ☑ Adults (22 years old and greater) | ? | {4} 510(k) Summary Apollo TMS Therapy System MAG & MORE # 510(k) Summary This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirement of 21 CFR 807.92. | 510(k) Owner: | MAG & More GmbH Machtlfinger Straße 13 81379 Munich, Germany Phone: +49 (0)89 998 292 300 Fax: +49 (0)89 998 292 330 | | --- | --- | | Primary Contact: | Juliane Rieß | | Date Prepared: | 19-Feb-2026 | | Proprietary Name: | Apollo TMS Therapy System | | Common/Usual Name: | Repetitive Transcranial Magnetic Stimulation (rTMS) System | | Classification Name: | Repetitive Transcranial Magnetic Stimulation Device 21 CFR 882.5805, Product Code OBP | | Predicate Device: | NeuroStar Advanced Therapy System (K220127) Apollo TMS Therapy System (K180313, K232639, K243700) | # Intended Use The Apollo TMS Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. # Device Description and Function The Apollo TMS Therapy System is an electromagnetic device that non-invasively delivers a rapidly pulsed magnetic field to the cerebral cortex in order to activate neurons within a limited volume without inducing a seizure. This method of cortical stimulation by application of brief magnetic pulses to the head is known as Transcranial Magnetic Stimulation (TMS). The Apollo TMS Therapy System is comprised of the following principal components: - User Interface - Main Unit (with or without housing) - Stimulation Coil - Coil Positioning System The operator controls the Apollo TMS Therapy System via the user interface (application software "Stimware"). "Stimware" is a treatment and data management software that administers treatment protocols and the patient's individual stimulation dose determined by the patient's individual motor 510(k) Summary {5} 510(k) Summary Apollo TMS Therapy System MAG & MORE threshold. Stimulation is applied via the stimulation coil. For the treatment of major depressive disorder, the stimulation coil is positioned to the left dorsolateral prefrontal cortex (DLPFC) by means of the coil positioning system. The observed and documented increase in cortical excitability after high frequency rTMS has been shown to persist beyond the duration of the train of stimulation. ## Performance Standards The Apollo TMS Therapy System conforms to the following recognized consensus standards: - ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process - IEC 60601-1 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance - IEC 60601-1-2 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests - IEC 60601-1-6 Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability - IEC 62304 Medical device software - Software life cycle processes ## Further Applicable Standards The Apollo TMS Therapy System complies with applicable requirements of the following additional standards: - ISO 14971 Medical devices - Application of risk management to medical devices - ISO 15223 Medical devices - Symbols to be used with medical device labels, labeling and information to be supplied - Part 1: General requirements - IEC 81001-5-1 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle ## Non-Clinical and Clinical Performance Data Apollo TMS Therapy System and its technological characteristics remain identical to that cleared within K180313, K232639 and K243700. No hardware changes have been made to the subject device, and no change to the already cleared 10 Hz treatment protocol was made. Thus new non-clinical performance testing was not required. The contents of this 510(k) complies with the FDA Guidance Document: "Class II Special Controls Guidance Document: Repetitive Transcranial Magnetic Stimulation (rTMS) Systems - Guidance for Industry and Food and Drug Administration Staff." Non-clinical performance testing was performed according to the standards listed above, including electrical safety, electromagnetic compatibility and biocompatibility and already cleared by the FDA earlier in K180313, K232639 and K243700. The efficacy and safety of the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode has been demonstrated in K220127 based on 2 randomized controlled trials and on supportive data from an open-label study and four 510(k) Summary {6} 510(k) Summary Apollo TMS Therapy System MAG & MORE observational studies (retrospective medical chart review), including a large-scale analysis of real-world data. The data referred to in K220127 demonstrated statistically significant and clinically meaningful improvements in anxiety symptoms. Clinical performance data has already shown that the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) is safe and effective. No additional clinical data is necessary to demonstrate safety and effectiveness. ## Software Verification and Validation Testing Software verification and validation testing was conducted and documented in accordance with IEC 62304 and internal quality procedures considered a well-established method as already used in K180313, K232639 and K243700. The 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." ## Risk Management Risk assessment is applied throughout the product development lifecycle process in accordance with the requirements set forth under the Agency recognized consensus standards ISO 14971 and IEC 62304. The results of the comprehensive risk analysis for the device indicate that there are no new hazards, harms, or safety risks introduced when compared to the predicate devices. The proposed changes for the Apollo TMS Therapy System are limited to labeling updates, specifically to include the treatment of adult patients with MDD who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode and may exhibit comorbid anxiety symptoms. These changes do not introduce any new safety or efficacy considerations. ## Substantial Equivalence The Apollo TMS Therapy System is substantially equivalent to its predicate devices, the NeuroStar Advanced Therapy System (K220127) and Apollo TMS Therapy System (K180313, K232639, K243700). The intended use and indications for use for the Apollo TMS Therapy System and primary predicate device are equivalent. The Apollo TMS Therapy System and the secondary predicate device have identical system components, consisting of a main unit (available in two variants 918001 Apollo and 918010 Apollo Light) including the stimulator, a stimulation coil, a coil positioning system, and the application software. The basic operational procedure is identical, and consists of system setup, patient preparation, coil positioning, determination of patient's motor threshold, and administration of treatment at predefined treatment stimulation parameters. Technological characteristics of the subject device are substantially equivalent to the primary predicate device NeuroStar Advanced Therapy System (K220127). 510(k) Summary Page 3 of 7 {7} 510(k) Summary Apollo TMS Therapy System MAG & MORE # Conclusions The indication for use, the target population, the treatment procedure, and the treatment spot are identical for the Apollo TMS Therapy System and the predicate devices NeuroStar Advanced Therapy System (K220127) and Apollo TMS Therapy System (K180313, K232639, K243700). The comparative non-clinical performance testing, such as the comparison of the electric and magnetic field output of the device, demonstrate that the Apollo TMS Therapy System is substantially equivalent to the predicate devices. All identified differences between the subject device, the Apollo TMS Therapy System, and its primary predicate device are minor and do not raise different questions of safety or effectiveness. This demonstrates that the Apollo TMS Therapy System is as safe and effective for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder as the primary predicate device. Therefore, the Apollo TMS Therapy System is substantially equivalent to its predicate devices NeuroStar Advanced Therapy System (K220127) and Apollo TMS Therapy System (K180313, K232639, K243700). 510(k) Summary Page 4 of 7 {8} 510(k) Summary Apollo TMS Therapy System MAG & MORE Substantial Equivalence Comparison | Characteristic | Subject Device | Predicate Device | Secondary Predicate | | --- | --- | --- | --- | | 510(k) Number | N/A | K220127 | K180313, K232639, K243700 | | Device Trade Name | Apollo TMS Therapy System | NeuroStar Advanced Therapy System | Apollo TMS Therapy System | | 510(k) submitter | MAG & More GmbH Machtlfinger Straße 13 81379 Munich, Germany | Neuronetics, Inc. 3222 Phoenixville Pike Malvern, PA 19355 | MAG & More GmbH Machtlfinger Straße 13 81379 Munich, Germany | | Indications for use | The Apollo TMS Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. | The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory improvement from previous antidepressant medication treatment in the current episode. | The Apollo TMS Therapy System is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. | | Target population | Adult patients | Adult patients | Adult patients | | Product Code | OBP | OBP | OBP | | Classification | 21 CFR 882.5805 | 21 CFR 882.5805 | 21 CFR 882.5805 | | Standard Treatment Stimulation Parameters | | | | 510(k) Summary {9} 510(k) Summary Apollo TMS Therapy System MAG & MORE | Characteristic | Subject Device | Predicate Device | Secondary Predicate | | --- | --- | --- | --- | | Area of brain to be stimulated | Left DLPFC | Left DLPFC | Left DLPFC | | Stimulation intensity | 120% of MT | 120% MT | 120% of MT | | %MT range | 50% to 150% MT | 25% to 140% MT | 50% to 150% MT | | Stimulation frequency | 10 Hz | 10 Hz | 10 Hz | | Pulse train duration | 4 sec | 4 sec | 4 sec | | Inter-train interval | 11 – 26 sec | 11 – 26 sec | 11 – 26 sec | | Trains per session | 75 | 75 | 75 | | Max No. of Pulses | 3,000 | 3,000 | 3,000 | | Output Stimulation Parameters | | | | | Amplitude in SMT units | 0 – 2.0 SMT | 0.22 – 2.08 SMT | 0 – 2.0 SMT | | Pulse width (± accuracy) | 167μs ± 10 % | 185 μs | pCool coils: 162 μs ± 1.9 μs aCool coils: 163 μs ± 2.5 μs | | Pulse train duration (sec) | 0.04 - 2000 | 1 - 600 | 0.04 - 2000 | | ITI range (sec) | 1 - 65 | 0 - 600 | 1 - 65 | 510(k) Summary Page 6 of 7 {10} 510(k) Summary Apollo TMS Therapy System MAG & MORE | Characteristic | Subject Device | | Predicate Device | Secondary Predicate | | | --- | --- | --- | --- | --- | --- | | Max # of pulses per session | 75,000 | | 5,000 | 75,000 | | | Stimulation Coil Parameters | | | | | | | Coil | pCool coils: HANS-pCool PMD70-pCool | aCool coils: HANS-aCool PMD70-aCool | Ferromagnetic Coil | pCool coils: HANS-pCool PMD70-pCool | aCool coils: HANS-aCool PMD70-aCool | | Configuration | figure-of-eight coil | | figure-of-eight coil | figure-of-eight coil | | | Output waveform | biphasic | | biphasic | biphasic | | | Cooling | passive cooling | active air-cooling | air | passive cooling | active air-cooling | | E-Field at 1.0 SMT | 130 V/m | | 135 V/m | 130 V/m | | | Coil Positioning System | Integrated into Head-and-Neck support system, landmark-aided coil placement or TMS cap for standardized 10-20-EEG positioning with coil positioning arm | | Integrated into Head Support System Laser-aided coil placement | Integrated into Head-and-Neck support system, landmark-aided coil placement or TMS cap for standardized 10-20-EEG positioning with coil positioning arm | | NOTE: Only the standard treatment protocol parameters have been cleared. Other stimulation parameters have not been cleared or evaluated for safety and effectiveness. 510(k) Summary --- **Source:** [https://fda.innolitics.com/device/K260560](https://fda.innolitics.com/device/K260560) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com