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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 / K253875

510(k) cleared

OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens

Visco Vision, Inc. · Oct 23, 2026 · K253875

FDA cleared the OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens from Visco Vision, Inc. on Oct 23, 2026 under K253875, a traditional 510(k). The device falls under product code LPL, Lenses, Soft Contact, Daily Wear, regulated at 21 CFR 886.5925 as a Class 2 device. The review panel was Ophthalmic.

FDA logged the submission as received on Dec 4, 2025. The decision came 323 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Visco Vision, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253875?

K253875 is the FDA 510(k) for OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens, submitted by Visco Vision, Inc.. FDA's decision date was Oct 23, 2026, under product code LPL (Lenses, Soft Contact, Daily Wear).

Who makes the OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens?

Visco Vision, Inc., based in Taoyuan City, is the applicant of record for K253875.

How long did the K253875 review take?

FDA received the submission on Dec 4, 2025 and issued its decision on Oct 23, 2026, 323 days later.

← All decisions in October 2026