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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 / K251684

510(k) cleared

Alma TED+ System

Alma Lasers, Inc. · Jun 5, 2026 · K251684

FDA cleared the Alma TED+ System from Alma Lasers, Inc. on Jun 5, 2026 under K251684, a traditional 510(k). The device falls under product code OAP, Laser, Comb, Hair, regulated at 21 CFR 890.5500 as a Class 2 device. The review panel was Physical Medicine.

FDA logged the submission as received on Jun 2, 2025. The decision came 368 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: K250071 (Alma FemiLift Pixel CO2 Laser System, Delivery Devices and Accessories).

Questions & Answers

What did FDA clear under K251684?

K251684 is the FDA 510(k) for Alma TED+ System, submitted by Alma Lasers, Inc.. FDA's decision date was Jun 5, 2026, under product code OAP (Laser, Comb, Hair).

Who makes the Alma TED+ System?

Alma Lasers, Inc., based in Buffalo Grove, IL, is the applicant of record for K251684.

How long did the K251684 review take?

FDA received the submission on Jun 2, 2025 and issued its decision on Jun 5, 2026, 368 days later.

← All decisions in June 2026

Sources