Si-Hy (olifilcon B) color silicone hydrogel soft contact lens— 510(k) K180322

Clearance details

Applicant

Visco Vision, Inc.

Product code

Code LPL

Device class

Class 2

Regulation

21 CFR 886.5925

Advisory panel

Ophthalmic

Date received

2018-02-05

Decision date

2018-04-20

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Taoyuan City, TW

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• 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

• K200618 — HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens2020-12-07
• K201080 — Daily Breeze B (olifilcon B) Spherical Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Toric Silicone Hydrogel Soft Contact Lens, Daily Breeze B (olifilcon B) Multifocal Silicone Hydrogel Soft Contact Lens2020-07-15
• K191397 — OxySoft (olifilcon C) silicone hydrogel soft contact lens2019-10-02
• K183670 — Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens +1 more2019-09-13
• K181349 — Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens +1 more2018-09-19

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 →