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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 / K251988

510(k) cleared

Boston iFace (Boston iFace)

Boston Aesthetics, Inc. · Jan 12, 2026 · K251988

FDA cleared the Boston iFace (Boston iFace) from Boston Aesthetics, Inc. on Jan 12, 2026 under K251988, a traditional 510(k). The device falls under product code GEI, Electrosurgical, Cutting & Coagulation & Accessories, regulated at 21 CFR 878.4400 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 199 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)), K251981 (Boston PICO (Boston PICO)), K252369 (Boston Pico755).

Questions & Answers

What did FDA clear under K251988?

K251988 is the FDA 510(k) for Boston iFace (Boston iFace), submitted by Boston Aesthetics, Inc.. FDA's decision date was Jan 12, 2026, under product code GEI (Electrosurgical, Cutting & Coagulation & Accessories).

Who makes the Boston iFace (Boston iFace)?

Boston Aesthetics, Inc., based in Wilmington, DE, is the applicant of record for K251988.

How long did the K251988 review take?

FDA received the submission on Jun 27, 2025 and issued its decision on Jan 12, 2026, 199 days later.

← All decisions in January 2026

Sources