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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 / K262752

510(k) cleared

Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)

Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. · Oct 23, 2026 · K262752

FDA cleared the Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9) from Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. on Oct 23, 2026 under K262752, a traditional 510(k). The device falls under product code OHS, Light Based Over The Counter Wrinkle Reduction, 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 Aug 3, 2026. The decision came 81 days later, inside the 90 FDA-day goal for a 510(k).

Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd. has one other decision in the tracker over the last 12 months: K253054 (LED Light Therapy Mask (M19, M19-1, M19-2, M19-3, M19-5, M19-6)).

Questions & Answers

What did FDA clear under K262752?

K262752 is the FDA 510(k) for Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9), submitted by Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd.. FDA's decision date was Oct 23, 2026, under product code OHS (Light Based Over The Counter Wrinkle Reduction).

Who makes the Facial Therapy Mask (Z1, Z2,Z3, Z5,Z6, Z7,Z8,Z9)?

Shenzhen Xinlong Precision Plastic Mold Products Co., Ltd., based in Shenzhen, is the applicant of record for K262752.

How long did the K262752 review take?

FDA received the submission on Aug 3, 2026 and issued its decision on Oct 23, 2026, 81 days later.

← All decisions in October 2026

Sources