Data / Medical devices / Taiwan / Pegavision Corporation-Daxi
Pegavision Corporation-Daxi: FDA-registered device maker in Taoyuan City, Taiwan, 15 510(k) clearances
Pegavision Corporation-Daxi is registered with the FDA (registration 3018616050) in Taoyuan City, Taiwan. It lists 2 device types. The FDA files 15 510(k) clearances under its listings, the newest dated May 21, 2026. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3018616050
- Address
- No. 255, Sec. 2, Renhe Rd., Daxi Dist., Taoyuan City, Taiwan, 335005
- Owner or operator
- PEGAVISION CORPORATION (10047630)
- Roles
- Complaint file establishment, Exporter to the US, Manufacturer
- First device listed
- October 14, 2014
- Registered through
- 2026
- Brand names listed
- Pegavision
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Lens, Contact, (Disposable) | MVN | 2 | Complaint file establishment, Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lenses, Soft Contact, Daily Wear | LPL | 2 | Complaint file establishment, 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 |
|---|---|---|---|---|---|---|
| May 21, 2026 | K253352 | Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact Lenses | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
| May 19, 2026 | K261299 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
| March 13, 2026 | K252385 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
| September 17, 2025 | K251095 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
| July 2, 2025 | K243868 | Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact Lenses | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
| May 8, 2024 | K232649 | Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
| May 31, 2023 | K222885 | Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
| February 2, 2022 | K211603 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
| December 6, 2021 | K211448 | Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
| October 21, 2020 | K201268 | Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) | LPL | Substantially Equivalent | Plexus Optix, Inc. | accessdata.fda.gov |
| October 15, 2020 | K200296 | Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
| December 19, 2016 | K161739 | Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
| October 15, 2014 | K140025 | AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
| April 23, 2013 | K123973 | AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
| April 17, 2012 | K120028 | AQUAMAX (ETAFILCON A) DISPOSABLE SOFT CONTACT LENSES | LPL | Substantially Equivalent | Pegavision Corporation | accessdata.fda.gov |
Compare with other makers
Updated May 21, 2026. 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.