FDA 510(k)

FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC

K-Number: K030593 · 2003-05-30

Decision Date2003-05-30

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC is the device name listed in this FDA 510(k) record. The listed applicant is X-Cel Contacts, A Walman Co.. It received FDA 510(k) clearance on 2003-05-30 under 510(k) number K030593. 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 FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC?

FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC is a medical device that received FDA 510(k) clearance on 2003-05-30. The listed applicant is X-Cel Contacts, A Walman Co.. The 510(k) number is K030593.

When did FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC receive FDA 510(k) clearance?

FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC received FDA 510(k) clearance on 2003-05-30, under 510(k) number K030593.

Who is the listed applicant for FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC?

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

What is the FDA product code for FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC?

The FDA product code for FLEXLENS AND HARRISON POST REFRACTIVE SURGERY (BIOXIFILCON A), (HIOXIFILCON B), (ACOFILCON A), (ACOFILCON B) SOFT CONTAC is LPL.

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Official Source

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