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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 / December 2025 / K253342

510(k) cleared

PICO-K

Speclipse, Inc. · Dec 24, 2025 · K253342

FDA cleared the PICO-K from Speclipse, Inc. on Dec 24, 2025 under K253342, 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 30, 2025. The decision came 85 days later, inside the 90 FDA-day goal for a 510(k).

Speclipse, Inc. has 2 other decisions in the tracker over the last 12 months: K261214 (PICO SHINING (PICO-K; PICOFY)), K253344 (BELLUS-Q).

Questions & Answers

What did FDA clear under K253342?

K253342 is the FDA 510(k) for PICO-K, submitted by Speclipse, Inc.. FDA's decision date was Dec 24, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the PICO-K?

Speclipse, Inc., based in Gyeonggi-Do, is the applicant of record for K253342.

How long did the K253342 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Dec 24, 2025, 85 days later.

← All decisions in December 2025

Sources