FDA 510(k)

Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens

K-Nummer: K182523 · 2018-11-01

Entscheidungsdatum2018-11-01

ProduktcodeLPL

BeratungsausschussOP

EntscheidungSubstantially Equivalent

Produktübersicht

Largan 55 UV Color (Ocufilcon D) 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 2018-11-01 under 510(k) number K182523. 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 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens?

Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2018-11-01. The listed applicant is Largan Medical Co., Ltd.. The 510(k) number is K182523.

When did Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens receive FDA 510(k) clearance?

Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens received FDA 510(k) clearance on 2018-11-01, under 510(k) number K182523.

Who is the listed applicant for Largan 55 UV Color (Ocufilcon D) 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 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens?

The FDA product code for Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens is LPL.

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