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510(k) Data Aggregation
K Number
K243587Device Name
PureLift GLOW
Manufacturer
Xtreem Pulse LLC
Date Cleared
2025-03-06
(106 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Xtreem Pulse LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended 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.
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 gently glide 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.
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K Number
K230506Device Name
PureLift Pro Edition
Manufacturer
Xtreem Pulse
Date Cleared
2023-06-21
(117 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Xtreem Pulse
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for facial stimulation and indicated for over-the-counter cosmetic use.
Device Description
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.
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K Number
K221443Device Name
PureLift Pro Plus
Manufacturer
Xtreem Pulse LLC
Date Cleared
2022-10-21
(156 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Xtreem Pulse LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Intended for facial stimulation and indicated for-over-the counter cosmetic use.
Device Description
The PureLift Pro Plus is a hand-held device intended to apply electrical impulses to strategic locations on the face. The PureLift Pro Plus 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 (10).
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 3.7-volt battery, produces 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 with the use of conductive gel.
The PureLift Pro Plus 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.
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K Number
K190269Device Name
PureLift
Manufacturer
Xtreem Pulse, LLC
Date Cleared
2019-08-28
(201 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Xtreem Pulse, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
PureLift is intended for facial stimulation and indicated for over-the-counter cosmetic use.
Device Description
The PureLift is a hand-held device intended to apply electrical impulses to strategic locations on the face. The PureLift 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 (10). The device measures 13.4″ L x 4.8″ W x 4.3″ D. Its outer case is injection molded of thermoplastic resin and the probes consist of chrome-plated spheres. The device, powered by a 3.7-volt battery, produces low-level current that is transmitted through the two fixed, smooth spherical probes. To turn the device on, the power button is pushed. Then LCD screen will be displayed, 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. PureLift is intended to be used with a legally marketed electroconductive media. The PureLift 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.
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K Number
K173483Device Name
Pure Flow External Counter-Pulsation Device
Manufacturer
Xtreem Pulse, LLC
Date Cleared
2018-05-30
(198 days)
Product Code
DRN
Regulation Number
870.5225Why did this record match?
Applicant Name (Manufacturer) :
Xtreem Pulse, LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Pure Flow External Counter-Pulsation device is intended for the treatment of chronic stable angina that is refractory to optimal anti-anginal medical therapy and without options for revascularization. In addition, it is intended for use in healthy patients to provide improvement in vasodilation, increased blood flow. It is intended for use under the oversight of a healthcare professional.
Device Description
The Pure Flow External Counter-Pulsa-tion device is a mechanical device used to increase aortic pressure during early native heart diastole to augment myocardial perfusion, and to decrease aortic pressure during early native heart systole to reduce ventricular workload and vascular afterload.
The PureFlow consists of a main unit, and applied parts (computer monitor, keyboard, flexible tubes which connect to fabric cuffs, inside each cuff is an inflatable plastic balloon), EKG wires, and SpO2 sensors.
PureFlow works on the basis of external counter pulsation. The pressure is created by inflating a series of cuffs (similar to blood-pressure cuffs) that squeeze the extremities (calf's, thighs, buttocks) forcing blood back up to the heart on each heart cycle. This process ultimately restores (by force) sufficient blood flow to parts of the heart that is lacking oxygen. The treatment process generally spans for a period of 1 hour each day for a period of 35 total treatments. ECP Treatment is proven to develop existing pathways of oxygenated blood back to the heart muscle. In other words, External Counterpulsation Therapy restores pathways for adequate & necessary blood flow back to heart through vessels that already exist.
The device also utilizes the following cleared components: Cable/Lead wire (ECG/EKG, SpO2, and Invasive Blood Pressure): K120010 LNCS/M-LNCS Oximetry Sensor: K101896
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