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FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall FDA approves Cordis Selution SLR, the first sirolimus drug-eluting balloon sold in the US FDA panel takes up GRAIL's Galleri cancer screening PMA on September 23 FDA folds the human factors guidance into eSTAR 7.1 and widens PreSTAR to five more meeting types AVAVA raises $45M with a third of it in debt from its lead investor UpFront Diagnostics wins a CE mark for a 10-minute stroke blood test Ambu pays $45M upfront for TIMS Medical and about 7,000 US hospital installs Citi downgrades Boston Scientific over the cyberattack recovery Autonomix puts Medtronic's former chief regulatory counsel on its board FDA calls the NOxBOXi oxygen leak fix a Class II correction, three years after a Class I recall

The Tracker / September 2026 / K261562

510(k) cleared

Diode Laser Therapy System

Sanhe LEFIS Electronics Co., Ltd. · Sep 10, 2026 · K261562

FDA cleared the Diode Laser Therapy System from Sanhe LEFIS Electronics Co., Ltd. on Sep 10, 2026 under K261562, 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 May 11, 2026. The decision came 122 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Sanhe LEFIS Electronics Co., Ltd. has 3 other decisions in the tracker over the last 12 months: K261204 (Intense Pulsed Light Therapy Device), K250998 (CO2 Laser Therapy System (Model: LFS-D9U)), K252319 (Q-Switched Nd: YAG Laser machine (LFS-C13U)).

Questions & Answers

What did FDA clear under K261562?

K261562 is the FDA 510(k) for Diode Laser Therapy System, submitted by Sanhe LEFIS Electronics Co., Ltd.. FDA's decision date was Sep 10, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Diode Laser Therapy System?

Sanhe LEFIS Electronics Co., Ltd., based in Langfang, is the applicant of record for K261562.

How long did the K261562 review take?

FDA received the submission on May 11, 2026 and issued its decision on Sep 10, 2026, 122 days later.

← All decisions in September 2026

Sources