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 / P250020

PMA approved

Belotero Volume (+) Lidocaine

Merz North America, Inc. · May 19, 2026 · P250020

FDA approved the Belotero Volume (+) Lidocaine from Merz North America, Inc. on May 19, 2026 under P250020, 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 26, 2025. The decision came 327 days later.

Merz North America, Inc. has one other decision in the tracker over the last 12 months: P250016 (Belotero® Intense (+) Lidocaine).

Questions & Answers

What did FDA approve under P250020?

P250020 is the FDA PMA for Belotero Volume (+) Lidocaine, submitted by Merz North America, Inc.. FDA's decision date was May 19, 2026, under product code LMH (Implant, Dermal, For Aesthetic Use).

Who makes the Belotero Volume (+) Lidocaine?

Merz North America, Inc., based in Raleigh, NC, is the applicant of record for P250020.

How long did the P250020 review take?

FDA received the submission on Jun 26, 2025 and issued its decision on May 19, 2026, 327 days later.

← All decisions in May 2026