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 / September 2025 / K251649

510(k) cleared

Sunny Plus (Sunny)

ShenB Co., Ltd. · Sep 18, 2025 · K251649

FDA cleared the Sunny Plus (Sunny) from ShenB Co., Ltd. on Sep 18, 2025 under K251649, a traditional 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 May 29, 2025. The decision came 112 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

ShenB Co., Ltd. has one other decision in the tracker over the last 12 months: K253926 (Diacore).

Questions & Answers

What did FDA clear under K251649?

K251649 is the FDA 510(k) for Sunny Plus (Sunny), submitted by ShenB Co., Ltd.. FDA's decision date was Sep 18, 2025, under product code NFO (Stimulator, Transcutaneous Electrical, Aesthetic Purposes).

Who makes the Sunny Plus (Sunny)?

ShenB Co., Ltd., based in Seoul, is the applicant of record for K251649.

How long did the K251649 review take?

FDA received the submission on May 29, 2025 and issued its decision on Sep 18, 2025, 112 days later.

← All decisions in September 2025

Sources