WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Exit Postmarket & security

THE TAPE

Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries Medtronic pays about $700M for rights to sell Cornerstone Robotics' Sentire outside the US Globus Medical wins a CE mark for Excelsius3D five years after FDA clearance GE HealthCare software updates dropped patients from monitoring, now a Class II recall Boston Scientific pulls Imager II catheters over degrading tips and ends the product line MiniMed wins a CE mark for the Flex insulin pump ahead of its year-end target Boston Scientific restarts shipping a week after the August 25 cyberattack ArthroTAK gets a second 510(k), adding knee tenodesis to its sutureless tendon anchor Oura files S-1 for Nasdaq IPO with $1.21B in nine-month revenue and 5 million paid members FDA confirms a Class I recall of Boston Scientific Infinion CX leads after 1,081 serious injuries

The Tracker / August 2026 / K261821

510(k) cleared

1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)

Zhengzhou PZ Laser Slim Technology Co., Ltd. · Aug 27, 2026 · K261821

FDA cleared the 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02) from Zhengzhou PZ Laser Slim Technology Co., Ltd. on Aug 27, 2026 under K261821, 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 87 days later, inside the 90 FDA-day goal for a 510(k).

Zhengzhou PZ Laser Slim Technology Co., Ltd. has 2 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)), K252732 (1927nm Thulium Laser System (PZ-DJG75-01, PZ-DJG75-02)).

Questions & Answers

What did FDA clear under K261821?

K261821 is the FDA 510(k) for 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02), submitted by Zhengzhou PZ Laser Slim Technology Co., Ltd.. FDA's decision date was Aug 27, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the 1565nm Laser Therapy Device (PZ-JG86-01,PZ-JG86-02)?

Zhengzhou PZ Laser Slim Technology Co., Ltd., based in Zhengzhou, is the applicant of record for K261821.

How long did the K261821 review take?

FDA received the submission on Jun 1, 2026 and issued its decision on Aug 27, 2026, 87 days later.

← All decisions in August 2026

Sources