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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K261589

510(k) cleared

1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)

Zhengzhou PZ Laser Slim Technology Co., Ltd. · Sep 2, 2026 · K261589

FDA cleared the 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02) from Zhengzhou PZ Laser Slim Technology Co., Ltd. on Sep 2, 2026 under K261589, 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 13, 2026. The decision came 112 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 3 other decisions in the tracker over the last 12 months: 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 K261589?

K261589 is the FDA 510(k) for 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02), submitted by Zhengzhou PZ Laser Slim Technology Co., Ltd.. FDA's decision date was Sep 2, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the 1927nm Thulium Laser System (PZ-DJG85-01, PZ-DJG85-02)?

Zhengzhou PZ Laser Slim Technology Co., Ltd., based in Zhengzhou, is the applicant of record for K261589.

How long did the K261589 review take?

FDA received the submission on May 13, 2026 and issued its decision on Sep 2, 2026, 112 days later.

← All decisions in September 2026

Sources