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PureLift

FDA 510(k)

Class II (US FDA 510(k))

510(k) K190269

by Xtreem Pulse, LLC

Identifiers

510(k) Number
K190269 FDA 510(k)
FDA Product Code
NFO FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 882.5890 FDA 510(k)
Regulation Number
882.5890 FDA 510(k)
Advisory Committee
Neurology FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

PureLift is a transcutaneous electrical stimulator intended for aesthetic purposes. It is classified as a Class II medical device under regulation number 882.5890.

The device received FDA 510(k) clearance (K190269) on August 28, 2019, and is substantially equivalent to a predicate device. It is manufactured by Xtreem Pulse, LLC and is indicated for use in neurology-related applications as per the advisory committee classification.

Frequently asked questions

What is PureLift intended for?

PureLift is a transcutaneous electrical stimulator intended for aesthetic purposes, as stated in its description and FDA classification under regulation 882.5890.

How was PureLift cleared for market?

PureLift received FDA 510(k) clearance (K190269) on August 28, 2019, as a substantially equivalent device to a predicate, following a traditional review pathway.

What regulatory classification does PureLift have?

PureLift is classified as a Class II medical device under regulation number 882.5890, with product code NFO and advisory committee classification in neurology.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Xtreem Pulse, LLC

Sources (1)

  • FDA 510(k) K190269 24 fields · synced Sep 21, 2026