PureLift GLOW— 510(k) K243587

Substantially Equivalent

Xtreem Pulse, LLC

FDA 510(k) clearance K243587 for PureLift GLOW, Substantially Equivalent on 2025-03-06. Applicant: Xtreem Pulse, LLC. Device class: 2.

Clearance details

Applicant: Xtreem Pulse, LLC
Product code: Code NFO
Device class: Class 2
Regulation: 21 CFR 882.5890
Advisory panel: Neurology
Date received: 2024-11-20
Decision date: 2025-03-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New York, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code NFO

K262861 — PureLift Pro Max2026-09-11
K260387 — SYNERJET PRO (SP-1003); InPhiuse (SP-1003); WOWJET (SP-1003)2026-08-31
K253932 — FACEGYM Pro Device (HD-109)2026-07-23
K260179 — VITA Multi-Function Head Brush (TB-2343F, TB-2442F)2026-06-03
K260895 — Ulike Clear Zero (YC10 BU)2026-05-28

More clearances from Xtreem Pulse, LLC

K221443 — PureLift Pro Plus2022-10-21
K190269 — PureLift2019-08-28
K173483 — Pure Flow External Counter-Pulsation Device2018-05-30

Data sourced from openFDA. This site is unofficial and independent of the FDA.