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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 / K261582

510(k) cleared

Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)

Zhengzhou PZ Laser Slim Technology Co., Ltd. · Aug 28, 2026 · K261582

FDA cleared the Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02) from Zhengzhou PZ Laser Slim Technology Co., Ltd. on Aug 28, 2026 under K261582, a traditional 510(k). The device falls under product code NUV, Massager, Vacuum, Light Induced Heating, 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 107 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 2 other decisions in the tracker over the last 12 months: 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 K261582?

K261582 is the FDA 510(k) for Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02), submitted by Zhengzhou PZ Laser Slim Technology Co., Ltd.. FDA's decision date was Aug 28, 2026, under product code NUV (Massager, Vacuum, Light Induced Heating).

Who makes the Vacuum Roller RF Slimming Device for Medical Use (PZ-FY66-01, PZ-FY66-02)?

Zhengzhou PZ Laser Slim Technology Co., Ltd., based in Zhengzhou, is the applicant of record for K261582.

How long did the K261582 review take?

FDA received the submission on May 13, 2026 and issued its decision on Aug 28, 2026, 107 days later.

← All decisions in August 2026

Sources