PureLift Pro Edition

K230506 · Xtreem Pulse · NFO · Jun 21, 2023 · Neurology

Device Facts

• Record ID: K230506
• Device Name: PureLift Pro Edition
• Applicant: Xtreem Pulse
• Product Code: NFO · Neurology
• Decision Date: Jun 21, 2023
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.5890
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

Intended for facial stimulation and indicated for over-the-counter cosmetic use.

Device Story

Hand-held device applies low-level electrical impulses to facial skin via two fixed, chrome-plated spherical probes. User-operated; powered by 3.7V rechargeable battery. Device alternates polarity between probes; user adjusts intensity (1-10) via buttons. Used with conductive serum to facilitate current transmission. Intended for cosmetic facial stimulation. Provides non-invasive, low-level electrical stimulation to facial muscles/tissue. Benefits include cosmetic facial enhancement. Operates with internal microprocessor control; includes automatic shut-off and 10-minute timer.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including conductivity analysis of the conductive serum and biocompatibility testing (ISO 10993-5, ISO 10993-10) for the serum. Electrical safety and EMC compliance confirmed via existing standards.

Technological Characteristics

Hand-held stimulator; 20.7cm x 4.8cm x 4.5cm. Materials: medical-grade biocompatible plastic enclosure, chrome-plated spherical probes. Energy: 3.7V rechargeable battery. Waveform: Monophasic rectangular pulses, alternating polarity. Frequency: 1.37-1.73kHz. Pulse width: 4µs. Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-10, IEC 60601-1-11. Biocompatibility: ISO 10993-5, ISO 10993-10. Microprocessor-controlled.

Indications for Use

Indicated for over-the-counter cosmetic facial stimulation.

Regulatory Classification

Identification

A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.

Predicate Devices

• PureLift Pro Plus (K221443)
• Lectron II Conductive Gel (K933804)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

June 21, 2023

Xtreem Pulse Jacqueline Schmainda Regulatory Consultant 353 W. 29th St., Suite 3 New York, New York 10001

Re: K230506

Trade/Device Name: PureLift Pro Edition Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO Dated: June 20, 2023 Received: June 21, 2023

Dear Jacqueline 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 (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

# Heather L. Dean -S

Heather Dean, PhD 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

Enclosure

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## Indications for Use

510(k) Number (if known) K230506

Device Name PureLift Pro Edition

| Indications for Use (Describe) |
|--------------------------------|
|--------------------------------|

| Intended for facial stimulation and indicated for over-the-counter cosmetic use. |
|----------------------------------------------------------------------------------|
|----------------------------------------------------------------------------------|

Prescription Use (Part 21 CFR 801 Subpart D)

X Over-The-Counter Use (21 CFR 801 Subpart C)

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# Submitter

| Applicant: | Xtreem Pulse<br>353 W. 29 St. Suite 3<br>New York, NY 10001<br>United States |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Persons: | Primary Correspondent<br>Jacqueline Schmainda<br>Regulatory Consultant<br>P: 763.269.2069<br>E: [e-mail]<br><br>Alternative Correspondent<br>Andrew Barile, CEO<br>Xtreem Pulse LLC<br>P: 917.597.5436<br>E: [e-mail] |
| Date Prepared: | June 21, 2023 |
| Device | |
| Trade Names: | PureLift Pro Edition |
| Classification Name: | Stimulator, Transcutaneous Electrical, Aesthetic Purposes |
| FDA Panel: | Neurology |
| Regulatory Class: | Class II |
| Product Code: | NEO |

21 CFR 882.5890

# Predicate Device

Regulation Number:

| Predicate<br>Type | 510(k) | Device Name | Manufacturer |
|-------------------|---------|---------------------------|----------------------------|
| Primary | K221443 | PureLift Pro Plus | Xtreem Pulse, LLC |
| Secondary | K933804 | Lectron II Conductive Gel | Cadwell Laboratories, Inc. |

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# Device Description

## PureLift Pro Edition

The PureLift Pro Edition device is a hand-held device intended to apply electrical impulses to strategic locations on the face. The device probes are designed for optimal contact with the face. The device continually alternates between the positive and negative probes and allow the user to adjust the settings for personalized comfort level by pressing the up/down button. The intensity starts at (1) and continues to (10).

The device measures 20.7cm (H) x 4.8cm (W) x 4.5cm (D). The outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device is powered by a 3.7-volt battery which produce a low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then the green LED light will illuminate indicating the unit is ready for use. Users then follow the instructions for use. The two probes gently glide over the skin to deliver low-level electrical impulses to strategic locations on the face of conductive gel.

The PureLift Pro Edition unit contains a power supply and rechargeable battery. The enclosure is made of medical grade biocompatible plastics and the output contacts (Probes) consist of chrome-plated spheres.

## Accessory

PureLift Pro Edition is provided with PureLift Activator Serum, a conductive gel.

## Indications for Use

Intended for facial stimulation and indicated for over-the-counter cosmetic use.

## Comparison of Technological Characteristics with the Predicate Device

A comparison of the intended use and technological characteristics of the PureLift products to the predicate PureLift device is provided in the following table:

| Element of<br>Comparison | PureLift Pro Plus<br>K221443 | PureLift Pro Plus Edition<br>K230506 – this submission |
|---------------------------------------------------|----------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------|
| Clearance Date | 21-Oct-2022 | TBD |
| Indications for Use | Intended for facial stimulation and<br>indicated for over-the-counter<br>cosmetic use. | Intended for facial stimulation and<br>indicated for over-the-counter<br>cosmetic use. |
| Dimensions (HxWxD) | 20.7cm x 4.8cm x 4.5cm | 20.7cm x 4.8cm x 4.5cm |
| Power Source | One 3.7V Battery | One 3.7V Battery |
| Number of output modes | 2 | 1 |
| Number of output channels | 1 output channel | 1 output channel |
| Regulated current or regulated<br>voltage? | Regulated current | Regulated current |
| Software/ Firmware/<br>Microprocessor<br>Control? | Yes | Yes |
| Automatic Shut off? | Yes | Yes |
| Element of | PureLift Pro Plus | PureLift Pro Plus Edition |
| Comparison | K221443 | K230506 - this submission |
| Patient override control? | No | No |
| Indicator Display | Yes | Yes |
| Timer range | 10 minutes only | 10 minutes only |
| Type of protection | Type BF | Type BF |
| On/off status | Yes | Yes |
| Standards Compliance | ANSI/AAMI ES60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>IEC 60601-1-11 | IEC 60601-1<br>IEC 60601-1-2<br>IEC 60601-2-10<br>IEC 60601-1-11 |
| Biocompatibility | ISO 10993-5<br>ISO 10993-10 | ISO 10993-5<br>ISO 10993-10 |
| Waveform | Pulses Monophasic, alternating<br>polarity | Pulses Monophasic, alternating<br>polarity |
| Shape | Rectangular Pulses | Rectangular Pulses |
| Maximum output voltage | 20Vpp(@500Ω)<br>32Vpp(@2kΩ)<br>44Vpp(@10kΩ) | 16.6Vpp(@500Ω)<br>27.0Vpp(@2kΩ)<br>38.4Vpp(@10kΩ) |
| Maximum output current | 9mA(@500Ω)<br>4.4mA(@2kΩ)<br>1.2mA(@10kΩ) | 7.7mA(@500Ω)<br>3.6mA(@2kΩ)<br>1.0mA(@10kΩ) |
| Output tolerance | +/- 1mA | +/- 1mA |
| Pulse Width | 4µs | 4µs |
| Frequency (Hz) | 1.37kHz~1.73kHz | 1.37kHz~1.73kHz |
| Symmetrical phases | Not multiphasic | Not multiphasic |
| Phase duration | 4µs | 4µs |
| Net Charge<br>(µC per pulse train) | 0µC per pulse train | 0µC per pulse train |
| Maximum Phase<br>Charge (µC) | 5.81µC@500Ω | 4.97µC@500Ω |
| Maximum current Density<br>(mA/cm2) | 8.8mA/cm2@500Ω | 7.5mA/cm2@500Ω |
| Maximum Power<br>Density | 39600µW/cm2 | 29250µW/cm2 |
| Pulse per burst | 30 pulses | 30 pulses |
| Bursts per second | 2740 ~ 3460 | 2740 ~ 3460 |
| Burst duration | 230µs | 230µs |
| Duty cycle | 0.63 ~ 0.80 | 0.63 ~ 0.80 |
| ON Time (seconds) | Constant | Constant |

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A comparison of the PureLift Activator Serum accessory to the predicate conductive gel is provided in the following table:

| Element of<br>Comparison | PureLift Activator Serum (accessory)<br>K230506 – this submission | Lectron II Conductive Gel<br>K933804 |
|--------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------|
| Intended Use | NA – the PureLift Activator Serum is only<br>intended for use with PureLift devices in<br>accordance with the intended use for these<br>devices. | NA – a 510(k) summary is not publicly<br>available. |
| Ingredients | Water, glycerin, chondus crispus extract<br>(seaweed), phenoxyethanol, sodium<br>hyaluronate, propylene glycol,<br>chrophenesin, ethylhexyglycerin, disodium<br>EDTA, sodium dehyroacetate, palmityl<br>tripeptide-5, citric acid | NA – a 510(k) summary is not publicly<br>available. |
| Performance<br>Testing | Comparisons to the Predicate Gel:<br>• Conductivity<br>• Maximum Voltage<br>• Maximum Current<br>• Frequency<br>• Pulse Width | Unknown |
| Biocompatibility | ISO 10993-5<br>ISO 10993-10 | NA - a 510(k) summary is not publicly<br>available. |

## Performance Data

No new or repeat design verification or design validation was required to support the substantial equivalence of the PureLift Pro Edition stimulator.

An analysis of the conductivity testing of the PureLift Activator Serum was performed. The analysis demonstrated that the PureLift Activator Serum has similar conductivity as the Lectron II conductive gel.

#### Biocompatibility

No new or repeat biocompatibility testing was required to substantial equivalence of the PureLift Pro Edition stimulator.

The following biocompatibility evaluations of the PureLift Activator Serum were conducted:

- . ISO 10993-5, Cytotoxicity
- ISO 10993-10, Sensitization
- ISO 10993-10, Irritation

Biocompatibility evaluations confirmed that the PureLift Activator Serum is non-cytotoxic, non-sensitizing, and non-irritating.

#### Electrical safety and electromagnetic compatibility (EMC)

No new or repeat EMC or electrical safety testing was required to support the substantial equivalence of the PureLift Pro Edition.

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## Software verification and validation

No new or repeat software verification or validation testing was required to support the substantial equivalence of the PureLift Pro Edition.

## Conclusions

The subject PureLift Pro Edition device is identical to the predicate device in terms of intended use and primary technological characteristics. Any differences between these devices were reviewed and confirmed to raise no new questions of safety or effectiveness. Additionally, the PureLift Activator Serum was assessed using performance data which confirmed that any differences between it and the predicate conductive gel did not raise new questions of safety or effectiveness. Thus, it is concluded that the PureLift Pro Edition is substantially equivalent to the predicate device.