FDA 510(k)

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)

Numéro K : K161098 · 2016-08-22

Date de décision2016-08-22

Code produitLPL

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) is the device name listed in this FDA 510(k) record. The listed applicant is Joowon Innovation Co., Ltd.. It received FDA 510(k) clearance on 2016-08-22 under 510(k) number K161098. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Questions fréquentes

What is the ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)?

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) is a medical device that received FDA 510(k) clearance on 2016-08-22. The listed applicant is Joowon Innovation Co., Ltd.. The 510(k) number is K161098.

When did ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) receive FDA 510(k) clearance?

ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) received FDA 510(k) clearance on 2016-08-22, under 510(k) number K161098.

Who is the listed applicant for ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)?

The FDA 510(k) record lists Joowon Innovation Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)?

The FDA product code for ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color) is LPL.

Essais cliniques associés

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Dispositifs connexes (Code : LPL)

Source officielle

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