FDA 510(k)

I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2

K-Number: K033136 · 2004-03-05

Decision Date2004-03-05

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 is the device name listed in this FDA 510(k) record. The listed applicant is Innova Vision, Inc.. It received FDA 510(k) clearance on 2004-03-05 under 510(k) number K033136. 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 I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2?

I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 is a medical device that received FDA 510(k) clearance on 2004-03-05. The listed applicant is Innova Vision, Inc.. The 510(k) number is K033136.

When did I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 receive FDA 510(k) clearance?

I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 received FDA 510(k) clearance on 2004-03-05, under 510(k) number K033136.

Who is the listed applicant for I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2?

The FDA 510(k) record lists Innova Vision, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2?

The FDA product code for I-LUX INNOVA BLUE TINT LENS, MODEL SUPER O2 is LPL.

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Other records listing Innova Vision, Inc. as applicant

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Official Source

View on FDA Database →

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