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FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K261817

510(k) cleared

Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)

Zhengzhou PZ Laser Slim Technology Co., Ltd. · Sep 17, 2026 · K261817

FDA cleared the Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02) from Zhengzhou PZ Laser Slim Technology Co., Ltd. on Sep 17, 2026 under K261817, 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 Jun 1, 2026. The decision came 108 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Zhengzhou PZ Laser Slim Technology Co., Ltd. has 4 other decisions in the tracker over the last 12 months: K261589 (1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)), K261582 (Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)), K261821 (1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)), K252732 (1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)).

Questions & Answers

What did FDA clear under K261817?

K261817 is the FDA 510(k) for Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02), submitted by Zhengzhou PZ Laser Slim Technology Co., Ltd.. FDA's decision date was Sep 17, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)?

Zhengzhou PZ Laser Slim Technology Co., Ltd., based in Zhengzhou, is the applicant of record for K261817.

How long did the K261817 review take?

FDA received the submission on Jun 1, 2026 and issued its decision on Sep 17, 2026, 108 days later.

← All decisions in September 2026

Sources