Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016— 510(k) K160344

Substantially Equivalent

Visco Vision, Inc.

FDA 510(k) clearance K160344 for Si-Hy (olifilcon B) sperical silicone hydrogel soft contact lens, Si-Hy (olifilcon B) multifocal silicone hydrogel soft contact lenses, Si-Hy (olifilcon B) toric silicone hydrogel soft contact lens2/16/2016, Substantially Equivalent on 2016-05-26. Applicant: Visco Vision, Inc..

Clearance details

Applicant: Visco Vision, Inc.
Product code: Code LPL
Advisory panel: Ophthalmic
Date received: 2016-02-08
Decision date: 2016-05-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Taoyuan City, TW

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Adverse events under product code LPL

product code LPL

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 →

Data sourced from openFDA. This site is unofficial and independent of the FDA.