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FDA 510(k)

Si-Hy (olifilcon B) color silicone hydrogel soft contact lens

K-Number: K180322 · 2018-04-20

Decision Date2018-04-20
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

Si-Hy (olifilcon B) color silicone hydrogel soft contact lens is the device name listed in this FDA 510(k) record. The listed applicant is Visco Vision, Inc.. It received FDA 510(k) clearance on 2018-04-20 under 510(k) number K180322. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Si-Hy (olifilcon B) color silicone hydrogel soft contact lens?

Si-Hy (olifilcon B) color silicone hydrogel soft contact lens is a medical device that received FDA 510(k) clearance on 2018-04-20. The listed applicant is Visco Vision, Inc.. The 510(k) number is K180322.

When did Si-Hy (olifilcon B) color silicone hydrogel soft contact lens receive FDA 510(k) clearance?

Si-Hy (olifilcon B) color silicone hydrogel soft contact lens received FDA 510(k) clearance on 2018-04-20, under 510(k) number K180322.

Who is the listed applicant for Si-Hy (olifilcon B) color silicone hydrogel soft contact lens?

The FDA 510(k) record lists Visco Vision, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Si-Hy (olifilcon B) color silicone hydrogel soft contact lens?

The FDA product code for Si-Hy (olifilcon B) color silicone hydrogel soft contact lens is LPL.

Related Clinical Trials

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Other records listing Visco Vision, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Related Devices (Code: LPL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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