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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 / K261964

510(k) cleared

ECHOLASER X4

Elesta S.P.A · Aug 19, 2026 · K261964

FDA cleared the ECHOLASER X4 from Elesta S.P.A on Aug 19, 2026 under K261964, 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 11, 2026. The decision came 69 days later, inside the 90 FDA-day goal for a 510(k).

Elesta S.P.A has one other decision in the tracker over the last 12 months: K260632 (LASER THERMAL THERAPY KIT).

Questions & Answers

What did FDA clear under K261964?

K261964 is the FDA 510(k) for ECHOLASER X4, submitted by Elesta S.P.A. FDA's decision date was Aug 19, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the ECHOLASER X4?

Elesta S.P.A, based in Calenzano, is the applicant of record for K261964.

How long did the K261964 review take?

FDA received the submission on Jun 11, 2026 and issued its decision on Aug 19, 2026, 69 days later.

← All decisions in August 2026

Sources