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FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home FDA opens a comment docket on the device regulatory science gaps of the next decade FDA makes the Boston Scientific Imager II removal a Class I recall Labs push the RESULTS Act after CMS cuts 775 test codes by the full 15 percent Boston Scientific clears SpaceOAR Flex, a rectal spacer the physician can stop mid-injection Shockwave founder Daniel Hawkins takes the board chair at Solenic Medical NeuroSigma takes its ADHD nerve stimulator into psychiatry clinics through Firefly's EEG network Intuitive wins a CE mark for adult cardiac surgery with da Vinci 5 Forj Medical opens a Costa Rica plant with ISO Class 8 cleanrooms and 50 staff Marani Health clears the M•care system for fetal and maternal monitoring at home

The Tracker / September 2026 / K241973

510(k) cleared

SmartIPL_NI System

Lumenis Be, Ltd. · Sep 19, 2026 · K241973

FDA cleared the SmartIPL_NI System from Lumenis Be, Ltd. on Sep 19, 2026 under K241973, 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 Jul 5, 2024. The decision came 806 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Lumenis Be, Ltd. has one other decision in the tracker over the last 12 months: K253803 (MILAN System).

Questions & Answers

What did FDA clear under K241973?

K241973 is the FDA 510(k) for SmartIPL_NI System, submitted by Lumenis Be, Ltd.. FDA's decision date was Sep 19, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the SmartIPL_NI System?

Lumenis Be, Ltd., based in Yokneam Ilit, is the applicant of record for K241973.

How long did the K241973 review take?

FDA received the submission on Jul 5, 2024 and issued its decision on Sep 19, 2026, 806 days later.

← All decisions in September 2026

Sources