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GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter GE HealthCare clears aortic stenosis and lung scanning software for Vscan Air FDA draws more than 500 comments on its generative AI device framework BRIJ Medical upsizes a $3M raise to $5M for its incision management line Globus Medical bought Synaptive Medical out of receivership in August Philips sets aside 288 million euros for a proposed DOJ settlement over its CPAP recall Rockwell Medical agrees to buy most of Vantive's hemodialysis business Blackstone puts $455M into Boston Scientific's VITALYST heart pump program 1nhaler raises £2.2M to take a cardboard inhaler into the clinic ONWARD Medical sold 88 ARC-EX systems in the third quarter

The Tracker / October 2026 / K262701

510(k) cleared

PicoPeak Picosecond Nd:Yag Laser System (Bella-9)

Beijing Sea Heart International Science and Technologyco.Ltd · Oct 22, 2026 · K262701

FDA cleared the PicoPeak Picosecond Nd:Yag Laser System (Bella-9) from Beijing Sea Heart International Science and Technologyco.Ltd on Oct 22, 2026 under K262701, 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 31, 2026. The decision came 83 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Beijing Sea Heart International Science and Technologyco.Ltd in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262701?

K262701 is the FDA 510(k) for PicoPeak Picosecond Nd:Yag Laser System (Bella-9), submitted by Beijing Sea Heart International Science and Technologyco.Ltd. FDA's decision date was Oct 22, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the PicoPeak Picosecond Nd:Yag Laser System (Bella-9)?

Beijing Sea Heart International Science and Technologyco.Ltd, based in Beijing, is the applicant of record for K262701.

How long did the K262701 review take?

FDA received the submission on Jul 31, 2026 and issued its decision on Oct 22, 2026, 83 days later.

← All decisions in October 2026