Visco Vision Inc.
Guishan Dist. Taoyuan, TW
Visco Vision Inc. appears in FDA device records in Guishan Dist. Taoyuan, TW. FDA records list 11 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 11 510(k) clearances for Visco Vision Inc. between 2015 and 2020. The busiest year on record is 2018, with 3. The most recent is 2020, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2015 | 1 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 3 |
| 2019 | 2 |
| 2020 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K200618 | HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact Lens | LPL | Substantially Equivalent | |
| 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 Lens | LPL | Substantially Equivalent | |
| K191397 | OxySoft (olifilcon C) silicone hydrogel soft contact lens | LPL | Substantially Equivalent | |
| K183670 | Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens ; OxyPure A (olifilcon A) Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens | LPL | Substantially Equivalent | |
| K181349 | Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact Lens | LPL | Substantially Equivalent | |
| K180322 | Si-Hy (olifilcon B) color silicone hydrogel soft contact lens | LPL | Substantially Equivalent | |
| K173958 | OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens | LPL | Substantially Equivalent | |
| K171447 | OxyPure Color Silicone Hydrogel Soft Contact Lenses | LPL | Substantially Equivalent | |
| K160245 | Visco (olifilcon A) soft contact lens | LPL | Substantially Equivalent | |
| K160344 | 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 | LPL | Substantially Equivalent | |
| K141348 | VISCO SOFT CONTACT LENS | LPL | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3004529384 | 3004529384 | Visco Vision Inc. | No. 1, Xingye St.,, Guishan Dist. Taoyuan 33341 TW | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain
