FDA 510(k)

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens

K-Nummer: K242916 · 2025-02-04

Entscheidungsdatum2025-02-04

ProduktcodeLPL

BeratungsausschussOP

EntscheidungSubstantially Equivalent

Produktübersicht

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Largan Medical Co., Ltd.. It received FDA 510(k) clearance on 2025-02-04 under 510(k) number K242916. 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 Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens?

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2025-02-04. The listed applicant is Largan Medical Co., Ltd.. The 510(k) number is K242916.

When did Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens receive FDA 510(k) clearance?

Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens received FDA 510(k) clearance on 2025-02-04, under 510(k) number K242916.

Who is the listed applicant for Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens?

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

What is the FDA product code for Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens?

The FDA product code for Largan U38 Color (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens is LPL.

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