FDA 510(k)

INTELLIWAVE3

K-Number: K100221 · 2010-09-14

Decision Date2010-09-14

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

INTELLIWAVE3 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 2010-09-14 under 510(k) number K100221. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTELLIWAVE3?

INTELLIWAVE3 is a medical device that received FDA 510(k) clearance on 2010-09-14. The listed applicant is Art Optical Contact Lens, Inc.. The 510(k) number is K100221.

When did INTELLIWAVE3 receive FDA 510(k) clearance?

INTELLIWAVE3 received FDA 510(k) clearance on 2010-09-14, under 510(k) number K100221.

Who is the listed applicant for INTELLIWAVE3?

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?

The FDA product code for INTELLIWAVE3 is LPL.

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Other records listing Art Optical Contact Lens, Inc. as applicant

K230824IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)K172314Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)K073621INTELLIWAVE, SOFT DAILY WEAR CONTACT LENS (ACOFILCON B) HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT

Related Devices (Code: LPL)

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.