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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 / July 2026 / P250016

PMA approved

Belotero® Intense (+) Lidocaine

Merz North America, Inc. · Jul 9, 2026 · P250016

FDA approved the Belotero® Intense (+) Lidocaine from Merz North America, Inc. on Jul 9, 2026 under P250016, an original premarket approval. The device falls under product code LMH, Implant, Dermal, For Aesthetic Use as a Class 3 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jun 17, 2025. The decision came 387 days later.

Merz North America, Inc. has one other decision in the tracker over the last 12 months: P250020 (Belotero Volume (+) Lidocaine).

Questions & Answers

What did FDA approve under P250016?

P250016 is the FDA PMA for Belotero® Intense (+) Lidocaine, submitted by Merz North America, Inc.. FDA's decision date was Jul 9, 2026, under product code LMH (Implant, Dermal, For Aesthetic Use).

Who makes the Belotero® Intense (+) Lidocaine?

Merz North America, Inc., based in Raleigh, NC, is the applicant of record for P250016.

How long did the P250016 review take?

FDA received the submission on Jun 17, 2025 and issued its decision on Jul 9, 2026, 387 days later.

← All decisions in July 2026