FDA 510(k)

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)

K-Nummer: K222885 · 2023-05-31

Entscheidungsdatum2023-05-31

ProduktcodeLPL

BeratungsausschussOP

EntscheidungSubstantially Equivalent

Produktübersicht

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) is the device name listed in this FDA 510(k) record. The listed applicant is Pegavision Corporation. It received FDA 510(k) clearance on 2023-05-31 under 510(k) number K222885. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Häufig gestellte Fragen

What is the Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)?

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) is a medical device that received FDA 510(k) clearance on 2023-05-31. The listed applicant is Pegavision Corporation. The 510(k) number is K222885.

When did Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) receive FDA 510(k) clearance?

Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) received FDA 510(k) clearance on 2023-05-31, under 510(k) number K222885.

Who is the listed applicant for Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)?

The FDA 510(k) record lists Pegavision Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)?

The FDA product code for Pegavision (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water) is LPL.

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