Medical Device Manufacturer · TW , Zhunan Township

Vizionfocus, Inc.

5 submissions · 5 cleared · Since 2018
5
Total
5
Cleared
0
Denied

Vizionfocus, Inc. — FDA 510(k) Submissions

Vizionfocus, Inc. has submitted 5 FDA 510(k) premarket notifications since 2018, of which 5 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Lenses, Soft Contact, Daily Wear . Use the specialty filter in the sidebar to narrow results.

5 devices
1–5 of 5
VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens
K251573 · LPL Lenses, Soft Contact,... · Ophthalmic
Sep 2025 111d
Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color)
K243953 · LPL Lenses, Soft Contact,... · Ophthalmic
Apr 2025 108d
VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens
K242413 · LPL Lenses, Soft Contact,... · Ophthalmic
Dec 2024 125d
Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses
K192225 · LPL Lenses, Soft Contact,... · Ophthalmic
Dec 2019 115d
ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)
K182247 · LPL Lenses, Soft Contact,... · Ophthalmic
Oct 2018 53d
Filters
Filter by Specialty
All5 Ophthalmic 5