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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 / December 2025 / K252673

510(k) cleared

LacertaMatrix

Lacerta Life Science · Dec 22, 2025 · K252673

FDA cleared the LacertaMatrix from Lacerta Life Science on Dec 22, 2025 under K252673, a traditional 510(k). The device falls under product code KGN, Wound Dressing With Animal-Derived Material(S) as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Aug 25, 2025. The decision came 119 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Lacerta Life Science has one other decision in the tracker over the last 12 months: K260218 (LacertaMatrix).

Questions & Answers

What did FDA clear under K252673?

K252673 is the FDA 510(k) for LacertaMatrix, submitted by Lacerta Life Science. FDA's decision date was Dec 22, 2025, under product code KGN (Wound Dressing With Animal-Derived Material(S)).

Who makes the LacertaMatrix?

Lacerta Life Science, based in Broussard, LA, is the applicant of record for K252673.

How long did the K252673 review take?

FDA received the submission on Aug 25, 2025 and issued its decision on Dec 22, 2025, 119 days later.

← All decisions in December 2025