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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K262861

510(k) cleared

PureLift Pro Max

Xtreem Pulse, LLC · Sep 11, 2026 · K262861

FDA cleared the PureLift Pro Max from Xtreem Pulse, LLC on Sep 11, 2026 under K262861, a special 510(k). The device falls under product code NFO, Stimulator, Transcutaneous Electrical, Aesthetic Purposes, regulated at 21 CFR 882.5890 as a Class 2 device. The review panel was Neurology.

FDA logged the submission as received on Aug 13, 2026. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Xtreem Pulse, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262861?

K262861 is the FDA 510(k) for PureLift Pro Max, submitted by Xtreem Pulse, LLC. FDA's decision date was Sep 11, 2026, under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Who makes the PureLift Pro Max?

Xtreem Pulse, LLC, based in New York, NY, is the applicant of record for K262861.

How long did the K262861 review take?

FDA received the submission on Aug 13, 2026 and issued its decision on Sep 11, 2026, 29 days later.

← All decisions in September 2026