Data / Medical devices / Taiwan / Unicon Optical Co., Ltd.
Unicon Optical Co., Ltd.: FDA-registered device maker in Hsinchu County Hsinchu(County), Taiwan, 4 510(k) clearances
Unicon Optical Co., Ltd. is registered with the FDA (registration 3013170070) in Hsinchu County Hsinchu(County), Taiwan. It lists 2 device types. The FDA files 4 510(k) clearances under its listings, the newest dated January 18, 2022. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3013170070
- Address
- No.16, Gongye E. 9th Rd. Hsinchu Science Park, Baoshan Township, Hsinchu County Hsinchu(County), Taiwan, 30075
- Owner or operator
- Unicon Optical Co., Ltd. (10052876)
- Roles
- Contract manufacturer, Exporter to the US, Manufacturer
- First device listed
- October 13, 2016
- Registered through
- 2026
- Brand names listed
- Alice H.A. Daily Soft Contact Lens, Alice Silicone 1-Day, Alice Silicone Bi-weekly Soft Contact Lens, Ivision, Qualis, To be notified, UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens, Unicon (Etafilcon A) Soft (hydrophilic) Contact Lens with UV Blocker for Daily Wear
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Contract manufacturer, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Contract manufacturer, Exporter to the US, 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 |
|---|---|---|---|---|---|---|
| January 18, 2022 | K213216 | Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens | LPL | Substantially Equivalent | Unicon Optical Co., Ltd. | accessdata.fda.gov |
| September 17, 2019 | K191929 | UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens | LPL | Substantially Equivalent | Unicon Optical Co., Ltd. | accessdata.fda.gov |
| May 16, 2019 | K182734 | Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac | LPL | Substantially Equivalent | Unicon Optical Co., Ltd. | accessdata.fda.gov |
| October 17, 2014 | K141917 | UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR | LPL | Substantially Equivalent | Unicon Optical Co., Ltd. | accessdata.fda.gov |
Compare with other makers
Updated January 18, 2022. 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.