Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens— 510(k) K232139

Clearance details

Applicant

Innova Vision, Inc.

Product code

Code LPL

Device class

Class 2

Regulation

21 CFR 886.5925

Advisory panel

Ophthalmic

Date received

2023-07-18

Decision date

2023-11-16

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Hsinchu, 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

• K240519 — Innova Vision (inifilcon A) Silicone Hydrogel (Hydrophilic) Daily Wear Soft Contact Lens2024-04-17
• K222954 — Innova Vision Hydrogel (Etafilcon A) Soft (Hydrophilic) Contact Lens2023-03-13
• K213119 — Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens2022-05-13
• K112373 — CALAVIEW COLOR (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR MODIFICATION2012-08-17
• K083288 — DISCON PLUS (ETAFILCON A) CONTACT LENS VISIBILITY TINT WITH UV BLOCKER2009-09-03

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 →