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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 / May 2026 / K253245

510(k) cleared

Boston 2910 (Boston 2910)

Boston Aesthetics, Inc. · May 21, 2026 · K253245

FDA cleared the Boston 2910 (Boston 2910) from Boston Aesthetics, Inc. on May 21, 2026 under K253245, 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 Sep 29, 2025. The decision came 234 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: K251981 (Boston PICO (Boston PICO)), K252369 (Boston Pico755), K251988 (Boston iFace (Boston iFace)).

Questions & Answers

What did FDA clear under K253245?

K253245 is the FDA 510(k) for Boston 2910 (Boston 2910), submitted by Boston Aesthetics, Inc.. FDA's decision date was May 21, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Boston 2910 (Boston 2910)?

Boston Aesthetics, Inc., based in Wilmington, DE, is the applicant of record for K253245.

How long did the K253245 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on May 21, 2026, 234 days later.

← All decisions in May 2026

Sources