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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 / K262070

510(k) cleared

Diode Laser Therapy Systems (DL612A)

Hebei Zollvan Medical Technology Co., Ltd. · Aug 19, 2026 · K262070

FDA cleared the Diode Laser Therapy Systems (DL612A) from Hebei Zollvan Medical Technology Co., Ltd. on Aug 19, 2026 under K262070, 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 22, 2026. The decision came 58 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Hebei Zollvan Medical Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262070?

K262070 is the FDA 510(k) for Diode Laser Therapy Systems (DL612A), submitted by Hebei Zollvan Medical Technology Co., Ltd.. FDA's decision date was Aug 19, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Diode Laser Therapy Systems (DL612A)?

Hebei Zollvan Medical Technology Co., Ltd., based in Baoding, is the applicant of record for K262070.

How long did the K262070 review take?

FDA received the submission on Jun 22, 2026 and issued its decision on Aug 19, 2026, 58 days later.

← All decisions in August 2026