Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses— 510(k) K200296

Clearance details

Applicant

Pegavision Corporation

Product code

Code LPL

Device class

Class 2

Regulation

21 CFR 886.5925

Advisory panel

Ophthalmic

Date received

2020-02-06

Decision date

2020-10-15

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Taoyuan City, TW

• K260507 — Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus2026-05-29
• K253352 — Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses +3 more2026-05-21
• K261299 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more2026-05-19
• K253885 — PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS +1 more2026-04-29
• K254269 — Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens +2 more2026-03-19

• K252385 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more2026-03-13
• K251095 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses2025-09-17
• K243868 — Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses +1 more2025-07-02
• K232649 — Pegavision (Hioxifilcon A) Daily Disposable Soft Contact Lenses2024-05-08
• K222885 — Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)2023-05-31

Injury

988

Other

4

Total

992

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →