Medical Device Manufacturer · TW , Taoyuan City

Pegavision Corporation - FDA 510(k) Cleared Devices

14 submissions · 14 cleared · Since 2012

Recent clearances: Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses

14
Total
14
Cleared
0
Denied

Pegavision Corporation, is a contact lens manufacturer with a manufacturing facility in Taoyuan City, Taiwan. The company specializes in soft contact lens design and production for vision correction.

Pegavision has received 14 FDA 510(k) clearances from 14 total submissions since 2012. The company focuses exclusively on Ophthalmic devices, with a strong track record in daily disposable and scheduled replacement soft contact lenses. The latest clearance was in 2026, confirming active regulatory engagement.

The company's product portfolio includes daily disposable soft contact lenses under the Pegavision and Aquamax brands, featuring various hydrophilic materials such as Etafilcon A, Hioxifilcon A, and Toufilcon B. Products range from standard daily disposables to color-enhanced lenses and bi-weekly replacement options.

Explore the complete list of cleared device names, product codes, and clearance dates in the FDA 510(k) database.

FDA 510(k) Regulatory Record - Pegavision Corporation

14 devices
1-12 of 14
Cleared May 21, 2026
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses
K253352 · LPL
Ophthalmic · 233d
Cleared May 19, 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K261299 · LPL
Ophthalmic · 29d
Cleared Mar 13, 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K252385 · LPL
Ophthalmic · 225d
Cleared Sep 17, 2025
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
K251095 · LPL
Ophthalmic · 160d
Cleared Jul 02, 2025
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K243868 · LPL
Ophthalmic · 197d
Cleared May 08, 2024
Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
K232649 · LPL
Ophthalmic · 251d
Cleared May 31, 2023
Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
K222885 · LPL
Ophthalmic · 250d
Cleared Feb 02, 2022
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses,...
K211603 · LPL
Ophthalmic · 254d
Cleared Dec 06, 2021
Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses,...
K211448 · LPL
Ophthalmic · 210d
Cleared Oct 15, 2020
Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact...
K200296 · LPL
Ophthalmic · 252d
Cleared Dec 19, 2016
Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable...
K161739 · LPL
Ophthalmic · 178d
Cleared Oct 15, 2014
AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
K140025 · LPL
Ophthalmic · 282d
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