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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 / June 2026 / P250021

PMA approved

saypha® ChiQ

Croma-Pharma GmbH · Jun 12, 2026 · P250021

FDA approved the saypha® ChiQ from Croma-Pharma GmbH on Jun 12, 2026 under P250021, 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 351 days later.

Croma-Pharma GmbH has one other decision in the tracker over the last 12 months: P240008 (saypha® MagIQ).

Questions & Answers

What did FDA approve under P250021?

P250021 is the FDA PMA for saypha® ChiQ, submitted by Croma-Pharma GmbH. FDA's decision date was Jun 12, 2026, under product code LMH (Implant, Dermal, For Aesthetic Use).

Who makes the saypha® ChiQ?

Croma-Pharma GmbH, based in Leobendorf, is the applicant of record for P250021.

How long did the P250021 review take?

FDA received the submission on Jun 26, 2025 and issued its decision on Jun 12, 2026, 351 days later.

← All decisions in June 2026