FDA 510(k)

METRO SOFT

K-Number: K100244 · 2010-10-28

Decision Date2010-10-28

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

METRO SOFT is the device name listed in this FDA 510(k) record. The listed applicant is Metro Optics of Austin, Inc.. It received FDA 510(k) clearance on 2010-10-28 under 510(k) number K100244. 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 METRO SOFT?

METRO SOFT is a medical device that received FDA 510(k) clearance on 2010-10-28. The listed applicant is Metro Optics of Austin, Inc.. The 510(k) number is K100244.

When did METRO SOFT receive FDA 510(k) clearance?

METRO SOFT received FDA 510(k) clearance on 2010-10-28, under 510(k) number K100244.

Who is the listed applicant for METRO SOFT?

The FDA 510(k) record lists Metro Optics of Austin, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for METRO SOFT?

The FDA product code for METRO SOFT is LPL.

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Other records listing Metro Optics of Austin, Inc. as applicant

K233221Metro Soft, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)K080512REVITALEYES, POST-SURGICAL SOFT DAILY WEAR CONTACT LENS (HIOXIFILCON B) CLEAR AND BLUE VISIBILITY TINT K031532SATUREEYES II (ACOFILCON A), (ACOFILCON B) & (TETRAFILCON A) SOFT CONTACT LENS FOR DAILY WEAR K001620METROFOCAL TORIC (POLYMACON) SOFT (MULTIFOCAL) DAILY WEAR CONTACT LENS (CLEAR & BLUE VISIBILITY TINT, LATHE-CUT FROM LEN K990264COMFORTKONE, KERATOCONUS ASPHERIC, RIGID GAS PERMEABLE (RGP), DAILY WEAR CONTACT LENS K964902CONTACT LENSES METRO-G 3X (HIOXIFILCON B)

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Related Devices (Code: LPL)

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.