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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 / November 2025 / K253344

510(k) cleared

BELLUS-Q

Speclipse, Inc. · Nov 25, 2025 · K253344

FDA cleared the BELLUS-Q from Speclipse, Inc. on Nov 25, 2025 under K253344, 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 56 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)), K253342 (PICO-K).

Questions & Answers

What did FDA clear under K253344?

K253344 is the FDA 510(k) for BELLUS-Q, submitted by Speclipse, Inc.. FDA's decision date was Nov 25, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the BELLUS-Q?

Speclipse, Inc., based in Gyeonggi-Do, is the applicant of record for K253344.

How long did the K253344 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Nov 25, 2025, 56 days later.

← All decisions in November 2025

Sources