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Xtreem Pulse, LLC

4 FDA records filed under this company name, from 2019 to 2026, in microcurrent and ems (NFO, 4).

The applicant is the company that filed with FDA. It can be the brand you know or a manufacturer that makes devices sold under other brand names; the device name as filed often shows which. We don't merge different company names, so check the A–Z list for related entries.

Electrical stimulation for aesthetic use (microcurrent and EMS) (NFO, 4)

510(k) cleared

PureLift Pro Max

510(k) number
K262861
Applicant
Xtreem Pulse, LLC
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

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

Copied from the text of FDA's 510(k) document (PDF, page 6), with line breaks removed.

510(k) cleared

PureLift GLOW

510(k) number
K243587
Applicant
Xtreem Pulse, LLC
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use

Not quoted here. The page with this statement is a scanned image whose text was machine-read, so we can't vouch for it word for word. Read FDA's PDF, page 4.

510(k) cleared

PureLift Pro Plus

510(k) number
K221443
Applicant
Xtreem Pulse, LLC
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

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

Copied from the text of FDA's 510(k) document (PDF, page 5), with line breaks removed.

510(k) cleared

PureLift

510(k) number
K190269
Applicant
Xtreem Pulse, LLC
Product code
NFO: Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Regulation
21 CFR 882.5890, Class II
FDA decision
Substantially Equivalent (SESE)
Received

Indications for use, as filed

“PureLift is intended for facial stimulation and indicated for over-the-counter cosmetic use.”

Copied from the text of FDA's 510(k) document (PDF, page 3), with line breaks removed.