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THE TAPE

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 / K261214

510(k) cleared

PICO SHINING (PICO-K; PICOFY)

Speclipse, Inc. · May 11, 2026 · K261214

FDA cleared the PICO SHINING (PICO-K; PICOFY) from Speclipse, Inc. on May 11, 2026 under K261214, a special 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 Apr 14, 2026. The decision came 27 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: K253342 (PICO-K), K253344 (BELLUS-Q).

Questions & Answers

What did FDA clear under K261214?

K261214 is the FDA 510(k) for PICO SHINING (PICO-K; PICOFY), submitted by Speclipse, Inc.. FDA's decision date was May 11, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the PICO SHINING (PICO-K; PICOFY)?

Speclipse, Inc., based in Gyeonggi-Do, is the applicant of record for K261214.

How long did the K261214 review take?

FDA received the submission on Apr 14, 2026 and issued its decision on May 11, 2026, 27 days later.

← All decisions in May 2026

Sources