WHERE ARE YOU?

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

THE TAPE

Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / May 2026 / K260618

510(k) cleared

Ulthera® System

Ulthera, Inc. · May 21, 2026 · K260618

FDA cleared the Ulthera® System from Ulthera, Inc. on May 21, 2026 under K260618, a traditional 510(k). The device falls under product code OHV, Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption, regulated at 21 CFR 878.4590 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Feb 25, 2026. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Ulthera, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K260618?

K260618 is the FDA 510(k) for Ulthera® System, submitted by Ulthera, Inc.. FDA's decision date was May 21, 2026, under product code OHV (Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption).

Who makes the Ulthera® System?

Ulthera, Inc., based in Raleigh, NC, is the applicant of record for K260618.

How long did the K260618 review take?

FDA received the submission on Feb 25, 2026 and issued its decision on May 21, 2026, 85 days later.

← All decisions in May 2026