Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more— 510(k) K252385
Substantially EquivalentPegavision Corporation
FDA 510(k) clearance K252385 for Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more, Substantially Equivalent on 2026-03-13. Applicant: Pegavision Corporation. Device class: 2.
Summary
Pegavision's record covers two toufilcon B lenses: Pegavision Daily Disposable Soft (Hydrophilic) Contact Lenses and Pegavision Soft (Hydrophilic) Contact Lenses. Both are filed under LPL, daily-wear soft contact lenses.
Class II, 21 CFR 886.5925. Ophthalmic is both the classification panel and the review panel, and it came in as a Traditional 510(k).
Pegavision filed from Taoyuan City, Taiwan. Review took 225 calendar days (July 31, 2025 to March 13, 2026).
Clearance details
- Device name as filed
- Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) 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
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- K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
- K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses +3 more
- 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
More clearances from Pegavision Corporation
view all- 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)
- K211603 — Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses, Aquamax (Etafilcon A) Soft (Hydrophilic) Contact Lenses
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.