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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) clearances
11
PMA records
0
Recall records
0
Registered establishments
1

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
510(k) clearance decisions for Visco Vision Inc., by decision year
YearClearances
20151
20162
20171
20183
20192
20202
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K200618HydroSens A (hioxifilcon A) Spherical Hydrogel Soft Contact LensLPLSubstantially Equivalent
K201080Daily 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 LensLPLSubstantially Equivalent
K191397OxySoft (olifilcon C) silicone hydrogel soft contact lensLPLSubstantially Equivalent
K183670Vexillum 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 LensLPLSubstantially Equivalent
K181349Vexillum (olifilcon B) with Tangible Polymers Silicone Hydrogel Soft Contact Lens; Daily Breeze (olifilcon B) Silicone Hydrogel Soft Contact LensLPLSubstantially Equivalent
K180322Si-Hy (olifilcon B) color silicone hydrogel soft contact lensLPLSubstantially Equivalent
K173958OxyAqua (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 lensLPLSubstantially Equivalent
K171447OxyPure Color Silicone Hydrogel Soft Contact LensesLPLSubstantially Equivalent
K160245Visco (olifilcon A) soft contact lensLPLSubstantially Equivalent
K160344Si-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 lens2/16/2016LPLSubstantially Equivalent
K141348VISCO SOFT CONTACT LENSLPLSubstantially Equivalent

Registered establishments

FDA registered establishments for Visco Vision Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30045293843004529384Visco Vision Inc.No. 1, Xingye St.,, Guishan Dist. Taoyuan 33341 TW2026

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