WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K254135

510(k) cleared

LipoSurg ARTIST

NOUVAG AG · Sep 5, 2026 · K254135

FDA cleared the LipoSurg ARTIST from NOUVAG AG on Sep 5, 2026 under K254135, a traditional 510(k). The device falls under product code QPB, System, Suction, Lipoplasty For Removal, regulated at 21 CFR 878.5040 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Dec 22, 2025. The decision came 257 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for NOUVAG AG in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K254135?

K254135 is the FDA 510(k) for LipoSurg ARTIST, submitted by NOUVAG AG. FDA's decision date was Sep 5, 2026, under product code QPB (System, Suction, Lipoplasty For Removal).

Who makes the LipoSurg ARTIST?

NOUVAG AG, based in Sankt Gallen, is the applicant of record for K254135.

How long did the K254135 review take?

FDA received the submission on Dec 22, 2025 and issued its decision on Sep 5, 2026, 257 days later.

← All decisions in September 2026