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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 / January 2026 / K251981

510(k) cleared

Boston PICO (Boston PICO)

Boston Aesthetics, Inc. · Jan 30, 2026 · K251981

FDA cleared the Boston PICO (Boston PICO) from Boston Aesthetics, Inc. on Jan 30, 2026 under K251981, 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 Jun 27, 2025. The decision came 217 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Boston Aesthetics, Inc. has 3 other decisions in the tracker over the last 12 months: K253245 (Boston 2910 (Boston 2910)), K252369 (Boston Pico755), K251988 (Boston iFace (Boston iFace)).

Questions & Answers

What did FDA clear under K251981?

K251981 is the FDA 510(k) for Boston PICO (Boston PICO), submitted by Boston Aesthetics, Inc.. FDA's decision date was Jan 30, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Boston PICO (Boston PICO)?

Boston Aesthetics, Inc., based in Wilmington, DE, is the applicant of record for K251981.

How long did the K251981 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Jan 30, 2026, 217 days later.

← All decisions in January 2026

Sources