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FDA 510(k)

DEFINITIVE, FLEXLENS - SILICONE HYDROGEL

K-Number: K100443 · 2010-10-28

ApplicantX-Cel Contacts, Inc.
Decision Date2010-10-28
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

DEFINITIVE, FLEXLENS - SILICONE HYDROGEL is the device name listed in this FDA 510(k) record. The listed applicant is X-Cel Contacts, Inc.. It received FDA 510(k) clearance on 2010-10-28 under 510(k) number K100443. 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 DEFINITIVE, FLEXLENS - SILICONE HYDROGEL?

DEFINITIVE, FLEXLENS - SILICONE HYDROGEL is a medical device that received FDA 510(k) clearance on 2010-10-28. The listed applicant is X-Cel Contacts, Inc.. The 510(k) number is K100443.

When did DEFINITIVE, FLEXLENS - SILICONE HYDROGEL receive FDA 510(k) clearance?

DEFINITIVE, FLEXLENS - SILICONE HYDROGEL received FDA 510(k) clearance on 2010-10-28, under 510(k) number K100443.

Who is the listed applicant for DEFINITIVE, FLEXLENS - SILICONE HYDROGEL?

The FDA 510(k) record lists X-Cel Contacts, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DEFINITIVE, FLEXLENS - SILICONE HYDROGEL?

The FDA product code for DEFINITIVE, FLEXLENS - SILICONE HYDROGEL 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.

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