FDA 510(k)

SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES

K-Number: K060821 · 2006-05-18

Decision Date2006-05-18

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES is the device name listed in this FDA 510(k) record. The listed applicant is Specialeyes, LLC. It received FDA 510(k) clearance on 2006-05-18 under 510(k) number K060821. 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 SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES?

SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES is a medical device that received FDA 510(k) clearance on 2006-05-18. The listed applicant is Specialeyes, LLC. The 510(k) number is K060821.

When did SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES receive FDA 510(k) clearance?

SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES received FDA 510(k) clearance on 2006-05-18, under 510(k) number K060821.

Who is the listed applicant for SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES?

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

What is the FDA product code for SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES?

The FDA product code for SPECIALEYES 50 AND SPECIALEYES 49 SHPERE AND TORIC SOFT CONTACT LENSES is LPL.

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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.