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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 / K250071

510(k) cleared

Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories

Alma Lasers, Inc. · Sep 24, 2025 · K250071

FDA cleared the Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories from Alma Lasers, Inc. on Sep 24, 2025 under K250071, a traditional 510(k). The device falls under product code GEX, Powered Laser Surgical Instrument, regulated at 21 CFR 878.4810 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Jan 10, 2025. The decision came 257 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Alma Lasers, Inc. has one other decision in the tracker over the last 12 months: K251684 (Alma TED+ System).

Questions & Answers

What did FDA clear under K250071?

K250071 is the FDA 510(k) for Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories, submitted by Alma Lasers, Inc.. FDA's decision date was Sep 24, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories?

Alma Lasers, Inc., based in Buffalo Grove, IL, is the applicant of record for K250071.

How long did the K250071 review take?

FDA received the submission on Jan 10, 2025 and issued its decision on Sep 24, 2025, 257 days later.

← All decisions in September 2025

Sources