Data / Medical devices / Taiwan / Vizionfocus Inc.
Vizionfocus Inc.: FDA-registered device maker in Zhunan Township Miaoli, Taiwan, 5 510(k) clearances
Vizionfocus Inc. is registered with the FDA (registration 3015146121) in Zhunan Township Miaoli, Taiwan. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated September 10, 2025. Registered through 2026. FDA data exported November 2, 2026.
SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.
- FDA registration number
- 3015146121
- Address
- No. 5, Renyi St., Zhunan Township Miaoli, Taiwan, 350
- Owner or operator
- VIZIONFOCUS INC. (10058872)
- Roles
- Manufacturer
- First device listed
- November 5, 2018
- Registered through
- 2026
- Brand names listed
- Altius, ArtMost® SiHy Soft Contact Lenses, Aurora, IDEAL® SiHy Contact Lenses, ILICON, ILICON Blue-Light Barrier Green-Tinted, ILICON Blue-Light Barrier Green-Tinted Color, ILICON Blue-Light Barrier Yellow-Tinted and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 10, 2025 | K251573 | VizionFocus (somofilcon A) Silicone Hydrogel Soft (hydrophilic) Contact Lens | LPL | Substantially Equivalent | Vizionfocus, Inc. | accessdata.fda.gov |
| April 10, 2025 | K243953 | Aurora (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lens (Tinted, Color) | LPL | Substantially Equivalent | Vizionfocus, Inc. | accessdata.fda.gov |
| December 17, 2024 | K242413 | VizionFocus (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens; VizionFocus Color (mififilcon A) Silicone Hydrogel Soft (hydrophilic) Daily Disposable Contact Lens | LPL | Substantially Equivalent | Vizionfocus, Inc. | accessdata.fda.gov |
| December 9, 2019 | K192225 | Legacy (Ocufilcon D) Performance- Tinted Soft (Hydrophilic) Daily Wear Contact Lenses | LPL | Substantially Equivalent | Vizionfocus, Inc. | accessdata.fda.gov |
| October 12, 2018 | K182247 | ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color) | LPL | Substantially Equivalent | Vizionfocus, Inc. | accessdata.fda.gov |
Compare with other makers
Updated September 10, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.