FDA 510(k)

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)

Numéro K : K220045 · 2022-08-05

Date de décision2022-08-05

Code produitLPL

Comité consultatifOP

DécisionSubstantially Equivalent

Résumé du dispositif

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is the device name listed in this FDA 510(k) record. The listed applicant is Dk Medivision Co., Ltd.. It received FDA 510(k) clearance on 2022-08-05 under 510(k) number K220045. 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 TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)?

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) is a medical device that received FDA 510(k) clearance on 2022-08-05. The listed applicant is Dk Medivision Co., Ltd.. The 510(k) number is K220045.

When did TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) receive FDA 510(k) clearance?

TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color) received FDA 510(k) clearance on 2022-08-05, under 510(k) number K220045.

Who is the listed applicant for TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)?

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

What is the FDA product code for TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)?

The FDA product code for TREVUES (polymacon) 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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