Data / Medical devices / Taiwan / Innova Vision Inc.
Innova Vision Inc.: FDA-registered device maker in Hsinchu City, Hsinchu(City), Taiwan, 5 510(k) clearances
Innova Vision Inc. is registered with the FDA (registration 3026035637) in Hsinchu City, Hsinchu(City), Taiwan. It lists 2 device types. The FDA files 5 510(k) clearances under its listings, the newest dated April 17, 2024. 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
- 3026035637
- Address
- No. 18, Prosperity Rd. 1, Hsinchu Science Park, Hsinchu City, Hsinchu(City), Taiwan, 300091
- Owner or operator
- INNOVA VISION INC. (9058871)
- Roles
- Manufacturer
- First device listed
- October 17, 2007
- Registered through
- 2026
- Brand names listed
- A+ Wave, Calaview Colors, Contact Lens, ExoLens, Innova, LENSES, SOFT CONTACT, DAILY WEAR, Soft Contact Lens, ZonedIn 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 |
|---|---|---|---|---|---|---|
| April 17, 2024 | K240519 | Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens | LPL | Substantially Equivalent | Innova Vision, Inc. | accessdata.fda.gov |
| March 13, 2023 | K222954 | Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens | LPL | Substantially Equivalent | Innova Vision, Inc. | accessdata.fda.gov |
| May 13, 2022 | K213119 | Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | LPL | Substantially Equivalent | Innova Vision, Inc. | accessdata.fda.gov |
| September 3, 2009 | K083288 | DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER | LPL | Substantially Equivalent | Innova Vision, Inc. | accessdata.fda.gov |
| June 7, 2007 | K062541 | CALAVIEW COLORS (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS | LPL | Substantially Equivalent | Innova Vision, Inc. | accessdata.fda.gov |
Compare with other makers
Updated April 17, 2024. 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.