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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 / K262628

510(k) cleared

Picosecond Laser treatment system (Z180)

Sanhe PERFECTLASER Technology Co., Ltd. · Oct 20, 2026 · K262628

FDA cleared the Picosecond Laser treatment system (Z180) from Sanhe PERFECTLASER Technology Co., Ltd. on Oct 20, 2026 under K262628, 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 29, 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 Sanhe PERFECTLASER Technology Co., Ltd. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K262628?

K262628 is the FDA 510(k) for Picosecond Laser treatment system (Z180), submitted by Sanhe PERFECTLASER Technology Co., Ltd.. FDA's decision date was Oct 20, 2026, under product code GEX (Powered Laser Surgical Instrument).

Who makes the Picosecond Laser treatment system (Z180)?

Sanhe PERFECTLASER Technology Co., Ltd., based in Langfang, is the applicant of record for K262628.

How long did the K262628 review take?

FDA received the submission on Jul 29, 2026 and issued its decision on Oct 20, 2026, 83 days later.

← All decisions in October 2026