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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 / K252833

510(k) cleared

VIVA combo RF System

Starmed Co., Ltd. · May 26, 2026 · K252833

FDA cleared the VIVA combo RF System from Starmed Co., Ltd. on May 26, 2026 under K252833, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 5, 2025. The decision came 263 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Starmed Co., Ltd. has one other decision in the tracker over the last 12 months: K251566 (TS-RF Generator (STS10)).

Questions & Answers

What did FDA clear under K252833?

K252833 is the FDA 510(k) for VIVA combo RF System, submitted by Starmed Co., Ltd.. FDA's decision date was May 26, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the VIVA combo RF System?

Starmed Co., Ltd., based in Goyang-Si, is the applicant of record for K252833.

How long did the K252833 review take?

FDA received the submission on Sep 5, 2025 and issued its decision on May 26, 2026, 263 days later.

← All decisions in May 2026

Sources