WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

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 / November 2025 / K252519

510(k) cleared

CO2 Laser Therapy System (K106)

Hebei Keylaser Sci-Tech Co.,Ltd · Nov 7, 2025 · K252519

FDA cleared the CO2 Laser Therapy System (K106) from Hebei Keylaser Sci-Tech Co.,Ltd on Nov 7, 2025 under K252519, 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 Aug 11, 2025. The decision came 88 days later, inside the 90 FDA-day goal for a 510(k).

Hebei Keylaser Sci-Tech Co.,Ltd has one other decision in the tracker over the last 12 months: K252515 (Q-Switched Nd:Yag laser (K690)).

Questions & Answers

What did FDA clear under K252519?

K252519 is the FDA 510(k) for CO2 Laser Therapy System (K106), submitted by Hebei Keylaser Sci-Tech Co.,Ltd. FDA's decision date was Nov 7, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the CO2 Laser Therapy System (K106)?

Hebei Keylaser Sci-Tech Co.,Ltd, based in Baoding, is the applicant of record for K252519.

How long did the K252519 review take?

FDA received the submission on Aug 11, 2025 and issued its decision on Nov 7, 2025, 88 days later.

← All decisions in November 2025

Sources