FDA 510(k)

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)

K-Nummer: K230824 · 2023-09-06

AntragstellerArt Optical Contact Lens, Inc.

Entscheidungsdatum2023-09-06

ProduktcodeLPL

BeratungsausschussOP

EntscheidungSubstantially Equivalent

Produktübersicht

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) is the device name listed in this FDA 510(k) record. The listed applicant is Art Optical Contact Lens, Inc.. It received FDA 510(k) clearance on 2023-09-06 under 510(k) number K230824. 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 IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)?

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) is a medical device that received FDA 510(k) clearance on 2023-09-06. The listed applicant is Art Optical Contact Lens, Inc.. The 510(k) number is K230824.

When did IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) receive FDA 510(k) clearance?

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) received FDA 510(k) clearance on 2023-09-06, under 510(k) number K230824.

Who is the listed applicant for IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)?

The FDA 510(k) record lists Art Optical Contact Lens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)?

The FDA product code for IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) is LPL.

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