Atlas FDA

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

FDA 510(k) clearance K173958 · decided 2018-04-03

Clearance details

K-number
K173958
Device name
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
Applicant
Visco Vision, Inc.
Decision
Substantially Equivalent
Date received
2017-12-28
Decision date
2018-04-03
Days to decision
96 days
Clearance type
Traditional
Product code
LPL
Device class
2
Regulation number
886.5925
Medical specialty
Ophthalmic
Advisory committee
Ophthalmic
Location
Taoyuan City, TW
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.