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Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours Apollo is in talks to buy J&J's DePuy Synthes for close to $20B BRAINBox signs Prolight to supply the readers for its concussion blood test Intuitive wins a CE mark for transvaginal surgery with the da Vinci SP Beta Bionics clears the Mint patch pump and cuts 2026 guidance the same day J&J sells the Laminar LAA program it bought for $400M upfront in 2023 GE HealthCare is in talks to buy Sofie Biosciences for about $1B Implicity raises $40M to run cardiac implant monitoring across four vendors Boston Scientific says plants and shipping are fully back 17 days after the cyberattack FDA seeks comment on device tracking and raises the burden estimate by 47,526 hours

The Tracker / September 2026 / K262269

510(k) cleared

CO2 Laser System (MBT- CO2 Laser)

Beijing Mega Beauty Technology Co., Ltd. · Sep 1, 2026 · K262269

FDA cleared the CO2 Laser System (MBT- CO2 Laser) from Beijing Mega Beauty Technology Co., Ltd. on Sep 1, 2026 under K262269, 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 6, 2026. The decision came 57 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Beijing Mega Beauty Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262269?

K262269 is the FDA 510(k) for CO2 Laser System (MBT- CO2 Laser), submitted by Beijing Mega Beauty Technology Co., Ltd.. FDA's decision date was Sep 1, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the CO2 Laser System (MBT- CO2 Laser)?

Beijing Mega Beauty Technology Co., Ltd., based in Beijing, is the applicant of record for K262269.

How long did the K262269 review take?

FDA received the submission on Jul 6, 2026 and issued its decision on Sep 1, 2026, 57 days later.

← All decisions in September 2026