Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses +3 more— 510(k) K253352
Substantially EquivalentPegavision Corporation
FDA 510(k) clearance K253352 for Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses +3 more, Substantially Equivalent on 2026-05-21. Applicant: Pegavision Corporation. Device class: 2.
Summary
Pegavision's record covers four Pegavision (Polymacon) lens names: Daily Disposable Soft (Hydrophilic), Soft (Hydrophilic), Color Daily Disposable Soft (Hydrophilic), and Color Soft (Hydrophilic) Contact Lenses. The product code is LPL, daily wear soft contact lenses.
Class II, 21 CFR 886.5925. Ophthalmic is both the classification panel and the review panel. The submission was a Traditional 510(k).
Pegavision filed from Taoyuan City, Taiwan. The decision came 233 calendar days after receipt (September 30, 2025 to May 21, 2026).
Clearance details
- Device name as filed
- 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
- Applicant
- Pegavision Corporation
- Product code
- Product code LPL
- Device class
- Class 2
- Regulation
- 21 CFR 886.5925
- Advisory panel
- Ophthalmic
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Taoyuan City, TW
Recent devices under product code LPL
view all- K262495 — Miru 1day UpSide (midafilcon A)
- K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
- K261299 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more
- K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS +1 more
- K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more
More clearances from Pegavision Corporation
view all- K252385 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more
- K251095 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
- K243868 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more
- K232649 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses
- K222885 — Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
Adverse events under product code LPL
product code LPL- Injury
- 988
- Other
- 4
- Total
- 992
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.