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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 / September 2025 / K251689

510(k) cleared

VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)

Nakanishi, Inc. · Sep 19, 2025 · K251689

FDA cleared the VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11) from Nakanishi, Inc. on Sep 19, 2025 under K251689, a traditional 510(k). The device falls under product code ELC, Scaler, Ultrasonic, regulated at 21 CFR 872.4850 as a Class 2 device. The review panel was Dental.

FDA logged the submission as received on Jun 2, 2025. The decision came 109 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Nakanishi, Inc. has 3 other decisions in the tracker over the last 12 months: K260773 (Varios Combi Pro2), K254163 (VarioSurg 4), K252662 (UniBur).

Questions & Answers

What did FDA clear under K251689?

K251689 is the FDA 510(k) for VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11), submitted by Nakanishi, Inc.. FDA's decision date was Sep 19, 2025, under product code ELC (Scaler, Ultrasonic).

Who makes the VARIOS 170 LUX SCALER SYSTEM (VA170LUXS10); VARIOS 170 LUX SCALER SYSTEM (VA170LUXS11); VARIOS 170 SCALER SYSTEM (VA170S11)?

Nakanishi, Inc., based in Kanuma, is the applicant of record for K251689.

How long did the K251689 review take?

FDA received the submission on Jun 2, 2025 and issued its decision on Sep 19, 2025, 109 days later.

← All decisions in September 2025

Sources