PureLift Pro Max

{0} FDA U.S. FOOD & DRUG ADMINISTRATION September 11, 2026 Xtreem Pulse, LLC Jackie Schmainda Regulatory Affairs 690 Washington St. Suite 4b New York, New York 10001 Re: K262861 Trade/Device Name: PureLift Pro Max Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: August 13, 2026 Received: August 13, 2026 Dear Jackie Schmainda: 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" (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). U.S. Food & Drug Administration 10903 New Hampshire Avenue Silver Spring, MD 20993 www.fda.gov {1} K262861 - Jackie Schmainda Page 2 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 more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). {2} K262861 - Jackie Schmainda Page 3 Sincerely, **Tushar Bansal -S** Tushar Bansal, PhD Acting Assistant Director, Acute Injury Devices Team 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 {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. | K262861 | ? | | Please provide the device trade name(s). | | ? | | PureLift Pro Max | | | | Please provide your Indications for Use below. | | ? | | Intended for facial stimulation and indicated for over-the-counter cosmetic use. | | | | Please select the types of uses. | ☐ 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 Submitter Information Date Prepared: September 10, 2026 Applicant: Xtreem Pulse, LLC 690 Washington St, #4B New York, NY 10014 Contact Person: Andrew Barile, CEO Xtreem Pulse, LLC P: 917.597.5436 E: andrew@xtreempulse.com Correspondent Name: Jackie Schmainda, Regulatory Consultant P: 763.269.2069 E: jaschmainda@gmail.com Device Identification Device Trade Name: PureLift Pro Max Common Name: Transcutaneous electrical nerve stimulator for pain relief Classification Name: Stimulator, Transcutaneous Electrical, Aesthetic Purposes Regulation Number: 21 CFR 882.5890 Product Code: NFO Predicate and Reference Devices K221443 PureLift Pro Plus (Xtreem Pulse, LLC) K011935 Rejuvenique Facial Toning System (Salton, Inc.) Page 1 of 7 {5} ## Device Description PureLift Pro Max is a hand-held, portable device intended to apply electrical impulses to strategic locations on the face. The PureLift Pro Max probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allows the user to adjust the settings for personalized comfort level by pressing the up (+) / down (-) button. The intensity starts at 1 and continues to 12. The device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D). Its outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device, powered by a rechargeable 3.7-volt lithium ion battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. When the device is powered on, the device indicators illuminate to indicate operating status. Users then follow the instructions for use outlined in the User Manual. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face. ## Intended Use / Indications for Use Intended for facial stimulation and indicated for over-the-counter cosmetic use. ## Technological Comparison of Subject and Predicate Device | Device Characteristic | Predicate Device PureLift Pro Plus | Subject Device Pure Lift Pro Max | Reference Device Rejuvenique | Summary of Differences | | --- | --- | --- | --- | --- | | 510(k) Number | K221443 | K262861 | K011935 | NA | | Manufacturer | Xtreem Pulse LLC | Xtreem Pulse LLC | Salton, Inc. | Subject and predicate devices have same manufacturer | | Device Name | PureLift Pro Plus | PureLift Pro Max | Rejuvenique, Model #RJV10 | Different device names | | FDA Product Code | NFO | NFO | NFO | Same primary FDA product code | | FDA Regulation | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | Same applicable NFO regulation | | FDA Class | Class II | Class II | Class II | Same device classification | | Indications for Use | Intended for facial stimulation and indicated for over-the-counter cosmetic use. | Intended for facial stimulation and indicated for over-the-counter cosmetic use. | Rejuvenique is intended for cosmetic use. | Subject device has an identical indication to the predicate. Reference device provides contextual support only | | Dimensions (H x W x D) | 20.7cm x 4.8cm x 4.5cm | 20.7cm x 4.8cm x 4.5cm | Not compared | Subject and predicate devices have same finished device dimensions | | Power Source | One 3.7V battery | One 3.7V battery | Not compared | Subject and predicate devices have same battery-powered configuration | | Number of output | 2 | 3 | Not compared | Subject device adds one | Page 2 of 7 {6} | Device Characteristic | Predicate Device PureLift Pro Plus | Subject Device Pure Lift Pro Max | Reference Device Rejuvenique | Summary of Differences | | --- | --- | --- | --- | --- | | modes | | | | user-selectable stimulation mode. | | Number of output channels | 1 output channel | 1 output channel | Not compared | Subject and predicate devices have one output channel | | Regulated current or regulated voltage? | Regulated, current-limited output | Regulated, current-limited output | Not compared | Subject and predicate devices use same regulated current method of energy delivery | | Software / firmware / microprocessor control? | Yes | Yes | Not compared | Subject and predicate devices are both electronically / microprocessor controlled | | Automatic shut-off? | Yes | Yes | Not compared | Subject and predicate devices have the same automatic shut-off feature | | Patient override control? | No | No | Not compared | Subject and predicate devices have the same patient override control mechanism | | Indicator display? | Yes | Yes | Not compared | Subject and predicate devices have indicator displays | | Timer range | 10 minutes only | 10 minutes only | Not compared | Subject and predicate devices have the same fixed treatment duration | | Type of protection | Type BF | Type BF | Not compared | Subject and predicate devices have the same Type BF classification | | On / off status | Yes | Yes | Not compared | Subject and predicate devices have the same status characteristics | | Standards compliance | ANSI/AAMI ES 60601-1 IEC 60601-1-2 IEC 60601-2-10 IEC 60601-1-11 | ANSI/AAMI ES 60601-1 IEC 60601-1-2 IEC 60601-2-10 IEC 60601-1-11 | Not compared | Subject and predicate devices are each supported by their individual EMC and Electrical Safety evaluations | | Biocompatibility | ISO 10993-5 ISO 10993-10 | ISO 10993-5 ISO 10993-10 | Not compared | Subject and predicate devices share the same user-contacting materials and biocompatibility evaluations | | Waveform | Pulse monophasic, alternating polarity | Modes A/B: alternating-polarity rectangular pulses organized into 32-pulse bursts. Mode C: alternating positive and negative individual 2 μs pulses; no burst | Not compared | Modes A/B retain the predicate's burst-based waveform architecture. Mode C introduces an individual-pulse waveform organization. This difference does not raise different questions of safety or effectiveness. | Page 3 of 7 {7} | Device Characteristic | Predicate Device PureLift Pro Plus | Subject Device Pure Lift Pro Max | Reference Device Rejuvenique | Summary of Differences | | --- | --- | --- | --- | --- | | | | structure | | | | Shape | Rectangular pulses | Rectangular pulses | Not compared | Subject and predicate devices have the same waveform shape | | Maximum output voltage | 20Vpp (500 Ω) 32Vpp (2 kΩ) 44Vpp (10 kΩ) | 70vpp (500 Ω) 100Vpp (2 kΩ) 130Vpp (10 kΩ) | Not compared | Different, but technologically equivalent; the difference does not raise a different question of safety or effectiveness | | Maximum output current | 9 mA (500 Ω) 4.4 mA (2 kΩ) 1.2 mA (10 kΩ) | 10.5mA (500 Ω) 4.6 mA (2 kΩ) 1.4 mA (10 kΩ) | 37.6mA (500 Ω) 12.4 mA (2 kΩ) 2.8 mA (10 kΩ) | Different, but technologically equivalent; the difference does not raise a different question of safety or effectiveness | | Output tolerance | +/- 1 mA | +/- 1.5 mA | NA | Different, but technologically equivalent; the difference does not raise a different question of safety or effectiveness | | Maximum pulse width | 4 μs | 4 μs | Not compared | Subject and predicate devices have the same maximum pulse width | | Output frequency (500 Ω) | 1.37 kHz - 1.73 kHz | Modes A/B: 1.37 kHz - 1.73 kHz Mode C: 500Hz | Not compared | Modes A/B have the same frequency range as the predicate. Mode C operates at 500 Hz as part of the added stimulation mode | | Symmetrical phases | Not multiphasic | Not multiphasic | Not compared | Subject and predicate devices have the same phase type | | Phase duration | 4 μs | Modes A/B: 4 μs Mode C: 2 μs | Not compared | Modes A/B have the same phase duration as the predicate. Mode C uses a shorter pulse duration | | Net charge (per pulse train) | 0 μC | 0 μC | Not compared | Subject and predicate devices have the same net charge | | Maximum phase charge (μC) | 5.81 μC (500 Ω) | 6.09 μC (500 Ω) | 11.3 μC (500 Ω) | Different, but technologically equivalent; the difference does not raise a different question of safety or effectiveness | | Maximum current density (mA/cm²) | 8.8 mA/cm² (500 Ω) | 10.6 mA/cm² (500 Ω) | 46.4 mA/cm² (500 Ω)² | Different, but technologically equivalent; the difference does not raise a different question of safety or effectiveness | | Maximum power density | 39,600 μW/cm² | 56,180 μW/cm² | Not compared | Different, but technologically equivalent; the difference does not raise a different question of safety or effectiveness | | Pulses per burst | 30 | Modes A/B: 32 Mode C: NA | Not compared | Different, but technologically equivalent; the difference does | Page 4 of 7 {8} | Device Characteristic | Predicate Device PureLift Pro Plus | Subject Device Pure Lift Pro Max | Reference Device Rejuvenique | Summary of Differences | | --- | --- | --- | --- | --- | | | | | | not raise a different question of safety or effectiveness | | Burst duration | 230 μs | 240 μs | Not compared | Different, but technologically equivalent; the difference does not raise a different question of safety or effectiveness | | Duty cycle | 0.63 - 0.80 | Modes A/B: 0.66 - 0.83 Mode C: NA | Not compared | Different, but technologically equivalent; the difference does not raise a different question of safety or effectiveness | | ON time (seconds) | Constant | Constant | Not compared | Subject and predicate devices have the same ON time | | OFF time (seconds) | None | None | Not compared | Subject and predicate devices have the same OFF time | | Accessory | PureLift Activator Serum (K243587) | PureLift Activator Serum (K243587) or other cosmetic conductive gel or serum | Not compared | The subject device expands the conductive-medium options to include other cosmetic conductive gels or serums. See discussion below | ## Discussion of Technological Differences The PureLift Pro Max has the same intended use and fundamental scientific technology as the predicate PureLift Pro Plus (K221443). Both devices are Class II devices under product code NFO intended for facial stimulation and over-the-counter cosmetic use. Both are handheld, battery-powered devices that deliver controlled electrical stimulation to the facial skin using the same basic device configuration, regulated output architecture, electrode configuration, pulse-based waveform, treatment duration, and method of application. The primary differences between the subject and predicate devices are the addition of a third stimulation mode and quantitative increases in certain electrical output characteristics, including maximum voltage, current, phase charge, current density, and power density. Minor quantitative differences are also present in output tolerance, pulses per burst, burst duration, and duty cycle. These differences do not change the device's intended use, fundamental operating principle, method of energy delivery, anatomical application site, or mechanism of tissue interaction. Rather, they represent modifications to the operating parameters of the same fundamental electrical stimulation technology. The increased stimulation capabilities and addition of Mode C were implemented through software/firmware modifications. No physical internal hardware, circuitry, components, or physical construction were changed from the predicate PureLift Pro Plus to enable these modifications. The hardware configuration remains unchanged from the predicate device. The increased electrical output parameters do not introduce a new type of hazard or raise different questions of safety or effectiveness. These differences were evaluated using electrical safety and Page 5 of 7 {9} performance testing, software verification and validation, thermal testing, and risk-management activities applicable to the subject device. The predicate specifies PureLift Activator Serum (K243587). The subject device may be used with PureLift Activator Serum (K243587) or another cosmetic conductive gel or serum. The conductive medium serves the same function of facilitating electrical contact between the device electrodes and the skin and does not alter the device's intended use, operating principle, or method of energy delivery. The conductive medium is not relied upon to control or increase the device's maximum electrical output, which is limited by the device's regulated output and protective controls. Accordingly, use of another cosmetic conductive gel or serum does not raise different questions of safety or effectiveness. The FDA-cleared Rejuvenique System (K011935) is included only as a reference device to provide additional context for selected electrical output characteristics. Rejuvenique has higher maximum output current, maximum phase charge, maximum current density, and pulse duration than the subject PureLift Pro Max. These data demonstrate that values exceeding the PureLift Pro Max for these individual parameters have previously been evaluated in an FDA-cleared NFO cosmetic electrical stimulation device. Because Rejuvenique differs in waveform, electrode configuration, duty cycle, and overall stimulation-delivery profile, it is not relied upon to establish substantial equivalence or to replace subject-device-specific performance and safety testing. ### Non-Clinical Testing **Electrical Safety and Electromagnetic Compatibility (EMC) Evaluations:** Testing was conducted on finished PureLift Pro Max devices and demonstrated compliance with the ANSI/AAMI ES 60601-1, IEC 60601-1-11, and IEC 60601-2-10 standards for electrical safety and IEC 60601-1-2 standard for electromagnetic compatibility Electrical safety and performance evaluations included limitation of voltage, current and energy; accuracy of controls and protection against hazardous output; leakage current; dielectric strength; and electrical-stimulator-specific output safety. Verification testing evaluated protection against excessive electrical stimulation. Worst-case thermal testing evaluated the potential for excessive heating at the electrode-skin interface. ### Biocompatibility Biocompatibility evaluation was conducted in accordance with ISO 10993-1 and included evaluation for cytotoxicity, sensitization, irritation ### Software Verification and Validation Software verification and validation were performed for the subject PureLift Pro Max device. The software verification and validation activities passed, software validation was confirmed, no unresolved anomalies were identified, and the software was accepted for system-level release. Page 6 of 7 {10} ## Bench Performance Testing Bench performance testing included evaluation of power input; limitation of voltage, current or energy; accuracy of controls and protection against hazardous outputs; leakage currents; dielectric strength; accessible parts; acoustic energy; ball pressure; drop test; environment; marking; mold stress relief; push test; temperature; vibration. ## Clinical Testing Clinical testing was not required to support a substantial equivalence determination. ## Substantial Equivalence Conclusion Based on the comparison of intended use and technological characteristics, the subject PureLift Pro Max device is substantially equivalent to the predicate PureLift Pro Plus (K221443) device. The subject device has the same intended use and fundamental electrical-stimulation technology as the predicate. The identified differences consist of quantitative changes to selected electrical-output characteristics and the addition of Mode C, which uses an individual-pulse rather than burst-based waveform architecture. These differences have been evaluated through electrical performance, thermal, software verification and validation, and risk management activities and do not raise different questions of safety or effectiveness. The Rejuvenique System (K011935) provides additional contextual support for selected electrical output parameters but is not relied upon as the predicate device. Accordingly, the differences between the subject PureLift Pro Max and predicate PureLift Pro Plus devices do not adversely affect the substantial equivalence determination. Page 7 of 7