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Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets Comments close on FDA's generative AI device framework Solventum clears its Restrata matrix for use under V.A.C. negative pressure therapy Medtronic takes a CE mark for five conduction system pacing pacemakers Paradromics hands Siemens Healthineers the imaging workup for its brain implant Empyrean submits a 510(k) for Vektra, its robotic brachytherapy system Masimo clears AFib detection on the Radius VSM wearable monitor Sequel clears the twiist insulin pump for adults with type 2 diabetes FTC issues a second request on the MiMedx purchase of Sanara MedTech Labcorp pays $722M upfront for BioReference testing assets

The Tracker / October 2025 / K252732

510(k) cleared

1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)

Zhengzhou PZ Laser Slim Technology Co., Ltd. · Oct 23, 2025 · K252732

FDA cleared the 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02) from Zhengzhou PZ Laser Slim Technology Co., Ltd. on Oct 23, 2025 under K252732, 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 28, 2025. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

Zhengzhou PZ Laser Slim Technology Co., Ltd. has 4 other decisions in the tracker over the last 12 months: K261817 (Diode Laser Therapy System (PZ-BDT67-01, PZ-BDT67-02)), 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)).

Questions & Answers

What did FDA clear under K252732?

K252732 is the FDA 510(k) for 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02), submitted by Zhengzhou PZ Laser Slim Technology Co., Ltd.. FDA's decision date was Oct 23, 2025, under product code GEX (Powered Laser Surgical Instrument).

Who makes the 1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)?

Zhengzhou PZ Laser Slim Technology Co., Ltd., based in Zhengzhou, is the applicant of record for K252732.

How long did the K252732 review take?

FDA received the submission on Aug 28, 2025 and issued its decision on Oct 23, 2025, 56 days later.

← All decisions in October 2025

Sources