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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 / October 2025 / K252427

510(k) cleared

Diode Laser Hair Removal Machine (GLD01)

Sanhe Meditech Co., Ltd. · Oct 31, 2025 · K252427

FDA cleared the Diode Laser Hair Removal Machine (GLD01) from Sanhe Meditech Co., Ltd. on Oct 31, 2025 under K252427, 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 1, 2025. The decision came 91 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sanhe Meditech Co., Ltd. has 2 other decisions in the tracker over the last 12 months: K260375 (Nd: YAG Laser Therapy Systems), K260257 (CO2 Laser System).

Questions & Answers

What did FDA clear under K252427?

K252427 is the FDA 510(k) for Diode Laser Hair Removal Machine (GLD01), submitted by Sanhe Meditech Co., Ltd.. FDA's decision date was Oct 31, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Diode Laser Hair Removal Machine (GLD01)?

Sanhe Meditech Co., Ltd., based in Sanhe, is the applicant of record for K252427.

How long did the K252427 review take?

FDA received the submission on Aug 1, 2025 and issued its decision on Oct 31, 2025, 91 days later.

← All decisions in October 2025

Sources