Reusable 3 Button Fingerswitch Wand

{0} FDA U.S. FOOD & DRUG ADMINISTRATION January 27, 2026 Soniquence, LLC Suzanne Lucas QA/RA Manager 2477 Grand Ave. Baldwin, New York 11510 Re: K254220 Trade/Device Name: Reusable 3 Button Fingerswitch Wand Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical Cutting And Coagulation Device And Accessories Regulatory Class: Class II Product Code: GEI Dated: December 22, 2025 Received: December 29, 2025 Dear Suzanne Lucas: 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. U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K254220 - Suzanne Lucas Page 2 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" (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 System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181). 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 systems (QS) regulation (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- {2} K254220 - Suzanne Lucas Page 3 assistance/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 K. Chem -S Digitally signed by Colin K. Chen -S Date: 2026.01.27 10:20:55 -05'00' 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 {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. | K254220 | ? | | Please provide the device trade name(s). | | ? | | Reusable 3 Button Fingerswitch Wand | | | | Please provide your Indications for Use below. | | ? | | The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, dissection, incision, and hemostasis in soft tissue surgical procedures | | | | 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) | ? | {4} 5 Soniquence 510(k) SUMMARY (As required by 21 CFR 807.92(a)) K254220 Date Prepared December 23, 2025 Submitter's Information (807.92(a)(1)) Company Name and Address: Soniquence, LLC 2477 Grand Avenue Baldwin, NY 11510 Phone: (516) 634-1370 www.soniquence.com Establishment Registration: 3014982808 Contact Information: Suzanne Lucas QA/RA Manager Soniquence, LLC Phone: (516) 654-4000 Fax: (516) 654-8000 Email: slucas@soniquence.com Device Information (807.92(a)(2)) Trade Name: Soniquence 3 Button Fingerswitch Wand Common/Usual Name: Electrosurgical, Cutting & Coagulation Device & Accessories Classification Name and Regulation: Electrosurgical Cutting and Coagulation Device and Accessories, 21 CFR 878.4400 Classification Panel: General and Plastic Surgery Device Class/Product Code FDA Classification: Class 2 FDA Product Code: GEI Soniquence, LLC. 2477 Grand Avenue, Baldwin, NY 11510-3531 U.S.A. (516) 654-4000 • Fax: (516) 654-8000 www.soniquence.com {5} Page 2 of 5  # S # Soniquence ## Predicate Devices (807.92(a)(3)) - Soniquence 3 Button Fingerswitch Handpiece, disposable (K183611) - Soniquence 3 Button Fingerswitch Handpiece, reusable (K212222) ## Device Description (807.92(a)(4)) The Soniquence 3-Button Fingerswitch Wand is an accessory intended for use with the Soniquence SmoothWave RF Generator. The device connects to a high-frequency generator via a male connector, and the distal female connector interfaces with a compatible Soniquence monopolar electrode. The device is supplied non-sterile and is intended for use with Soniquence monopolar electrodes. The 3-Button Fingerswitch Wand provides user access to three monopolar waveforms without the need for generator front-panel manipulation. The handpiece enables activation of CUT, BLEND, and HEMO modes via integrated finger-actuated switches. When a button is depressed, the corresponding mode is activated regardless of the generator display settings. Visual indicators illuminate to confirm activation of the selected mode. a) The CUT button will activate CUT mode. When depressed, the yellow indicator (CUT) illuminates. b) The BLEND button will activate BLEND mode. When depressed, the yellow indicator (BLEND) illuminates. c) The HEMO button will activate the HEMO mode. When depressed, the blue indicator (HEMO) illuminates. ## Intended Use ### Subject Device Intended Use The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, dissection, incision, and hemostasis in soft tissue surgical procedures ### Predicate Device Intended Use (K183611) Disposable 3 Button Fingerswitch Wand The Soniquence 3 Button Fingerswitch Handpiece is designed to be used exclusively with a Soniquence RF Generator and the Soniquence monopolar electrodes for resection, dissection, incision and hemostasis in soft tissue surgical procedures. ### Predicate Device Intended Use (K212222) Reusable 3 Button Fingerswitch Wand The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, dissection, incision, and hemostasis in soft tissue surgical procedures. {6} 5 Soniquence # Substantial Equivalence Comparison (807.92(a)(6)) The Soniquence 3 Button Fingerswitch Wand is substantially equivalent in intended use, technological characteristics, operating principle, and performance characteristics to the predicate device. | Characteristic | Soniquence Reusable 3 Button Fingerswitch Wand (SUBJECT DEVICE) | Soniquence disposable 3 Button Fingerswitch Wand (PREDICATE DEVICE K183611) | Soniquence reusable 3 Button Fingerswitch Wand (PREDICATE DEVICE K212222) | | --- | --- | --- | --- | | Intended Use | The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, dissection, incision, and hemostasis in soft tissue surgical procedures | The Soniquence 3 Button Fingerswitch Wand is designed to be used exclusively with a Soniquence RF Generator and the Soniquence monopolar electrodes for resection, dissection, incision and hemostasis in soft tissue surgical procedures. | The Soniquence Reusable 3 Button Fingerswitch Wand is designed to be used with a Soniquence RF Generator and Soniquence monopolar electrodes for resection, dissection, incision, and hemostasis in soft tissue surgical procedures | | Regulation number | 878.4400 | Identical | Identical to both | | Product Code | GEI | Identical | Identical to both | | OTC or Prescription | RX Only | Identical | Identical to both | | Device Classification | Class II | Identical | Identical to both | | Modes | Monopolar Cut, Blend, and HEMO modes | Identical | Identical to both | | Operating mechanism | Button Switch | Identical | Identical to both | | Energy Source | RF Energy | Identical | Identical to both | | Cable length (m) | 3m | Identical | Identical to both | | Activation method | Hand control | Identical | Identical to both | | Materials | Housing: Aluminum Alloy | Housing: ABS | Identical to disposable 3 Button Fingerswitch Wand K183611 | | | Activation buttons: Silicone rubber compound | Activation buttons: ABS | Identical to disposable 3 Button Fingerswitch Wand K183611 | | | Button cover: Polyphenylsulfone | Button cover: ABS | Identical to disposable 3 Button Fingerswitch Wand K183611 | | | Internal electronics: Printed circuit board (PCB) | Identical | Identical to both | | | Cable insulation: Silicone | Cable insulation: PVC | Identical to disposable 3 Button Fingerswitch Wand K183611 | Page 3 of 5 {7} 5 Soniquence | Characteristic | Soniquence Reusable 3 Button Fingerswitch Wand (SUBJECT DEVICE) | Soniquence disposable 3 Button Fingerswitch Wand (PREDICATE DEVICE K183611) | Soniquence reusable 3 Button Fingerswitch Wand (PREDICATE DEVICE K212222) | | --- | --- | --- | --- | | Safety standards used | • IEC 60601-1 (Electrical safety) • IEC 60601-2-2 (HF surgical equipment) | Identical | Identical to both | | Biocompatibility | • ISO 10993-11: 2017 Acute systemic toxicity • ISO 10993-10:2021 Skin Sensitization • ISO 10993-23:2021 Intracutaneous irritation • USP-NF General Chapters 151 – Pyrogen test • ISO 10993-5:2009 MTT Cytotoxicity | Identical | Identical to both | | Sterility method | Pre-Vacuum Sterilization | EO Sterilization | Steris V-Pro Sterilization | ## Non-Clinical Testing (807.92(b)(1)) The Soniquence 3-Button Fingerswitch Wand was developed in accordance with the design control requirements of 21 CFR 820.30. Appropriate non-clinical verification and validation testing was conducted to address identified risks and to support the safety and effectiveness of the device. ## Testing included: - IEC 60601-1: Medical electrical equipment – General requirements for basic safety and essential performance - IEC 60601-2-2: Medical electrical equipment – Particular requirements for the basic safety and essential performance of high-frequency surgical equipment and accessories ## Biocompatibility Biocompatibility testing was conducted in accordance with ISO 10993 for externally communicating devices with tissue contact. All tests met acceptance criteria. - ISO 10993-10:2010, Intracutaneous Reactivity Test - ISO 10993-10:2010, Skin Sensitization Test - ISO 10993-5:2009, Cytotoxicity - ISO 10993-11: 2017 Acute systemic toxicity - USP-NF General Chapters 151 – Pyrogen test Page 4 of 5 {8} Page 5 of 5 Soniquence # Sterilization Validation The device has undergone sterilization validation reprocessing with passing results according to the requirements of: - ISO 17664-1:2021 Processing of health care products — Information to be provided by the medical device manufacturer for the processing of medical devices — Part 1: Critical and semi-critical medical devices - ISO 17665:2024 Sterilization of health care products — Moist heat — Requirements for the development, validation and routine control of a sterilization process for medical devices - AAMI TIR12:2020 Designing, testing, and labeling medical devices intended for processing by health care facilities: A guide for device manufacturers - ANSI/AAMI ST98:2022 Cleaning validation of health care products — Requirements for development and validation of a cleaning process for medical devices - ASTM F3208-20 Standard Guide for Selecting Test Soils for Validation of Cleaning Methods for Reusable Medical Devices # Clinical Testing (807.92(b)(2)) Clinical testing was not required to demonstrate substantial equivalence. # Conclusion (807.92(b)(3)) Based on the comparison of intended use, technological characteristics, and performance to the identified predicate devices, Soniquence, LLC concludes that the Soniquence 3 Button Fingerswitch Wand does not raise new or different questions of safety or effectiveness and is substantially equivalent to the predicate devices.