(106 days)
No
The device description focuses on electrical stimulation and LED technology with user-adjustable settings. There is no mention of AI or ML in the device description, intended use, or performance studies. The "Mentions AI, DNN, or ML" section explicitly states "Not Found".
Yes.
The device's stated "Intended Use / Indications for Use" explicitly includes "treatment of wrinkles" and "treatment of mild to moderate inflammatory acne," which goes beyond purely cosmetic effects and implies a therapeutic purpose.
No
The device is described as providing stimulation, treatment of wrinkles, and treatment of mild to moderate inflammatory acne; it does not mention any diagnostic capabilities.
No
The device description clearly outlines a physical, hand-held device with probes, LED technology, a battery, and injection-molded housing, indicating it is a hardware device with electrical and light-emitting components, not solely software.
Based on the provided information, the PureLift GLOW device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for facial and neck stimulation, treatment of wrinkles, and treatment of mild to moderate inflammatory acne. These are all cosmetic and therapeutic applications applied directly to the body, not tests performed on samples taken from the body (like blood, urine, or tissue).
- Device Description: The device applies electrical impulses and LED light to the skin. This is a physical interaction with the body, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting biomarkers, or providing diagnostic information about a disease or condition based on in vitro testing.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. The PureLift GLOW device does not fit this description.
N/A
Intended Use / Indications for Use
PureLift GLOW is intended for facial and neck stimulation, treatment of wrinkles, treatment of mild to moderate inflammatory acne, and indicated for over-the-counter cosmetic use.
Product codes
NFO, OHS
Device Description
PureLift GLOW is a hand-held device intended to apply electrical impulses to strategic locations on the face and Light Emitting Diode (LED) technology that is intended for the treatment of wrinkles and mild to moderate inflammatory acne.
The PureLift GLOW probes are designed for optimal contact with the LED technology is not intended to come into contact with the user. The device continually alternates between the positive probes and allows the user to adjust the settings for personalized comfort level by pressing the intensity starts at (1) and continues to (10). The LED treatment area is approximately 36.3cm2 and available five levels of blue (465nm) and red (634nm) wavelengths.
The device housing is injection molded of biocompatible thermoplastic resin and the probes consist of chrome-plated spheres. The device, powered by a 3.7-volt rechargeable battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pressed, and a green light illuminates to indicate that the unit is ready for use. Users then follow the instructions for use. The two probes qently qlide over the skin to deliver low-level to strategic locations on the face and neck with the use of a conductive gel and the LED light is directed to the treatment area.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Face and Neck
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-the-Counter (OTC)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following bench performance testing has been performed for the PureLift GLOW device:
- Power input
- Limitation of voltage, current or energy
- Accuracy of controls and instructions and protection against hazardous outputs
- Leakage currents and patient auxiliary currents
- Dielectric strength
- Accessible parts
- Acoustic energy
- Ball pressure
- Drop test
- Environment
- Marking
- Mold stress relief
- Push test
- Temperature
- Vibration
Clinical testing was not required to support a substantial equivalence determination.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
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.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym along with the full name of the agency on the right. The FDA part of the logo is in blue, with the acronym in a square and the full name written out to the right of it.
March 6, 2025
Xtreem Pulse LLC Jacqueline Schmainda Regulatory Consultant 353 W. 29th St., Suite 3 New York, New York 10001
Re: K243587
Trade/Device Name: PureLift GLOW Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NFO. OHS Dated: February 4, 2025 Received: February 4, 2025
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 (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"
1
(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 OS 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 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-reportingcombination-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 Rue"). 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-advicecomprehensive-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-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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
2
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
3
Indications for Use
Submission Number (if known)
Device Name
PureLift GLOW
Indications for Use (Describe)
PureLift GLOW is intended for facial and neck stimulation, treatment of wrinkles, treatment of mild to moderate inflammatory acne, and indicated for over-the-counter cosmetic use.
Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)
X Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
| 510(k) #: | K243587 |
|---|---|
| ----------- | --------- |
510(k) Summary
Prepared on: 2025-02-04
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Xtreem Pulse LLC | |
|---|---|---|
| Applicant Address | 353 W. 29th St., Suite 3 New York NY 10001 United States | |
| Applicant Contact Telephone | 917-597-5436 | |
| Applicant Contact | Mr. Andrew Barile | |
| Applicant Contact Email | andrew@xtreempulse.com | |
| Correspondent Name | Jacqueline Schmainda | |
| Correspondent Address | United States | |
| Correspondent Contact Telephone | 763-269-2069 | |
| Correspondent Contact | jaschmainda@gmail.com | |
| Correspondent Contact Email | jaschmainda@gmail.com | |
| Device Name | ||
| 21 CFR 807.92(a)(2) | ||
| Device Trade Name | PureLift GLOW | |
| Common Name | Transcutaneous electrical nerve stimulator for pain relief | |
| Classification Name | Stimulator, Transcutaneous Electrical, Aesthetic Purposes | |
| Regulation Number | 882.5890 | |
| Product Code(s) | NFO | |
| Legally Marketed Predicate Devices | ||
| 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K221443 | PureLift Pro Plus | NFO |
| K223482 | reVive Light Therapy® Wrinkle and Acne LED Device | OHS |
| K201782 | NuFace Trinity Plus Device | NFO |
| Device Description Summary | ||
| 21 CFR 807.92(a)(4) |
5
PureLift GLOW is a hand-held device intended to apply electrical impulses to strategic locations on the face and Light Emitting Diode (LED) technology that is intended for the treatment of wrinkles and mild to moderate inflammatory acne.
The PureLift GLOW probes are designed for optimal contact with the LED technology is not intended to come into contact with the user. The device continually alternates between the positive probes and allows the user to adjust the settings for personalized comfort level by pressing the intensity starts at (1) and continues to (10). The LED treatment area is approximately 36.3cm2 and available five levels of blue (465nm) and red (634nm) wavelengths.
The device housing is injection molded of biocompatible thermoplastic resin and the probes consist of chrome-plated spheres. The device, powered by a 3.7-volt rechargeable battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pressed, and a green light illuminates to indicate that the unit is ready for use. Users then follow the instructions for use. The two probes qently qlide over the skin to deliver low-level to strategic locations on the face and neck with the use of a conductive gel and the LED light is directed to the treatment area.
Intended Use/Indications for Use
PureLift GLOW is intended for facial and neck stimulation, treatment of mild to moderate inflammatory acne, and indicated for over-the-counter cosmetic use.
Indications for Use Comparison
The subject device is intended for facial and neck stimulation, treatment of mild to moderate inflammatory acne, and indicated for over-the-counter cosmetic use. The same indication for use in comparison to the following predicate/reference devices:
- K223482 Predicate Device: intended for the treatment of wrinkles and mild to moderate inflammatory acne
- K210782 Reference Device:intended for facial and neck stimulation and over-the-counter cosmetic use
Technological Comparison
The subject has similar technological characteristics as comparison to the predicate/reference device.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(5)
21 CFR 807.92(a)(6)
6
The following bench performance testing has been performed for the PureLift GLOW device:
- Power input
- Limitation of voltage, current or energy
- Accuracy of controls and instructions and protection against hazardous outputs
- Leakage currents and patient auxiliary currents
- Dielectric strength
- Accessible parts
- Acoustic energy
- Ball pressure
- Drop test
- Environment
- Marking
- Mold stress relief
- Push test
- Temperature
- Vibration
Clinical testing was not required to support a substantial equivalence determination.
7
Substantial Comparison Table
| Item | PureLift GLOW | PureLift Pro Plus | NuFace Trinity Plus | reVive Light Therapy Wrinkle
and Acne LED |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K243587 | K221443 | K201782 | K223482 |
| Regulation | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 882.5890 | 21 CFR 878.4810 |
| Product Code(s) | NFO/OLP | NFO | NFO | OHS/OLP |
| Class | Class II | Class II | Class II | Class II |
| Use Type | Over-the-Counter (OTC) | Over-the-Counter (OTC) | Over-the-Counter (OTC) | Over-the-Counter (OTC) |
| Device Name | Intended for facial and neck
stimulation, treatment of
wrinkles, treatment of mild to
moderate inflammatory acne,
and indicated for over-the-
counter cosmetic use. | Intended for facial stimulation
and indicated for over-the-
counter cosmetic use. | The NuFace Trinity Plus Device
is intended for facial and neck
stimulation and indicated for
over-the-counter cosmetic
use. | The reVive Light Wrinkle and
LED Device is intended for
treatment of wrinkles and mild
to moderate inflammatory
acne. |
| Irradiance Source | LED | N/A | N/A | LED |
| Anatomic Site | Face and Neck | Face | Face and Neck | Face |
| Treatment Area | 36.3cm2 | N/A | N/A | 7 cm2 |
| Type of Energy Output | Microcurrent | Microcurrent | Microcurrent | N/A |
| Treatment Method | Place directly on the skin | Place directly on the skin | N/A | Place directly on the skin |
| Treatment Time | 10 minutes | 10 minutes only | N/A | 3 minutes |
| Materials | Thermoplastic resin
enclosures, chrome-plated
spheres | Thermoplastic resin
enclosures, chrome-plated
spheres | N/A | N/A |
| Wavelengths (Wrinkle
Treatment) | 634nm | N/A | N/A | 605nm, 630nm, 660nm,
880nm |
| Wavelengths (Acne
Treatment) | 465nm | N/A | N/A | 415nm, 630nm |
| Item | PureLift GLOW | PureLift Pro Plus | NuFace Trinity Plus | reVive Light Therapy Wrinkle
and Acne LED |
| Dimensions (H x W x D) | 14.6cm x 6.1cm x 4.4cm | 20.7cm x 4.8cm x 4.5cm | 5.2in x 2.6in x 1.6in | N/A |
| Power Source | One 3.7V battery | One 3.7V battery | Internal rechargeable
Lithium Ion battery | Battery or universal USB power
source |
| Number of output modes | 2 | 2 | N/A | N/A |
| Number of output channels | 1 | 1 | 1 | N/A |
| Regulated current or
regulated voltage | Regulated current | Regulated current | Both | N/A |
| Software / Firmware /
Microprocessor Control | Yes | Yes | Yes | N/A |
| Automatic Shut Off | Yes | Yes | Yes | N/A |
| Patient Override Control | No | No | Yes | N/A |
| Indicator Display | Yes | Yes | N/A | N/A |
| Timer Range | 10 minutes only | 10 minutes only | N/A | N/A |
| Type of Protection | Type BF | Type BF | Type BF | N/A |
| On / Off Status | Yes | Yes | Yes | N/A |
| Standards Compliance | ANSI/AAMI ES60601-1
IEC 60601-1-2 | ANSI/ AAMI ES 60601-1
IEC 60601-1-2
IEC 60601-2-10
IEC 60601-1-11 | N/A | ANSI/ AAMI ES 60601-1
IEC 60601-1-2 |
| Biocompatibility | ISO 10993-5
ISO 10993-10 | ISO 10993-5
ISO 10993-10 | N/A | ISO 10993-5
ISO 10993-10 |
| ltem | PureLift GLOW | PureLift Pro Plus | NuFace Trinity Plus | reVive Light Therapy Wrinkle
and Acne LED |
| Waveform | Pulses monophasic,
alternating polarity | Pulses monophasic,
alternating polarity | N/A | N/A |
| Shape | Rectangular pulses | Rectangular pulses | N/A | N/A |
| Maximum Output Voltage | 9mA (@500Ω)
4.4mA (@2kΩ)
1.2mA (@10kΩ) | 9mA (@500Ω)
4.4mA (@2kΩ)
1.2mA (@10kΩ) | N/A | N/A |
| Maximum Output Current | 20Vpp (@500Ω)
32Vpp (@2kΩ)
44Vpp (@10kΩ) | 20Vpp (@500Ω)
32Vpp (@2kΩ)
44Vpp (@10kΩ) | N/A | N/A |
| Output Tolerance | ± 1mA | ± 1mA | N/A | N/A |
| Pulse Width | 4 µs | 4 µs | N/A | N/A |
| Frequency (Hz) | 1.37kHz ~ 1.73kHz | 1.37kHz ~ 1.73kHz | N/A | N/A |
| Symmetrical Phases | Non multiphasic | Non multiphasic | N/A | N/A |
| Phase Duration | 4 µs | 4 µs | N/A | N/A |
| Net Charge (µC per pulse
train) | 0 us per pulse train | 0 µs per pulse train | N/A | N/A |
| MaximumPhase Charge
(μC) | 5.81 µC @500Ω | 5.81 µC @500Ω | N/A | N/A |
| Maximum Current Density
(mA/cm2) | 8.8 mA/cm² @500Ω | 8.8 mA/cm- @500Ω | N/A | N/A |
| Maximum Density Power | 39600 µW/cm² | 39600 µW/cm² | N/A | N/A |
| Pulse Per Burst | 30 pulses | 30 pulses | 20 (10 positive and 10
negative) | N/A |
| Burst Per Second | 2740 ~ 3400 | 2740 ~ 3400 | 8.3 (@ 8.3 Hz) | N/A |
| Burst Duration | 230 us | 230 มร | 2.4s (@8.3 Hz) | N/A |
| Duty Cycle | 0.63 ~ 0.80 | 0.63 ~ 0.80 | Duty cyle: 50%
On
time per burst: 20.2s | N/A |
| ON Time (seconds) | Constant | Constant | 60 ms (@8.3 Hz) | N/A |
| ltem | PureLift GLOW | PureLift Pro Plus | NuFace Trinity Plus | reVive Light Therapy Wrinkle
and Acne LED |
| Indicator Displays | On/off status, low battery,
voltage current level | On/off status, low battery,
voltage current level | On/off status, low battery,
voltage current level | N/A |
| Accessory to Device | PureLift Activator Serum
(biocompatible, 510(k) cleared
per K221443) or other
cosmetic conductive gel or
serum | PureLift Activator Serum
(biocompatible, 510(k) cleared
per K221443) | NuFACE Gel Primer
(biocompatible, 510(k) cleared
per K161654) | N/A |
8
9
10