FDA 510(k)

DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT

K-Number: K954603 · 1996-01-04

Decision Date1996-01-04

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT is the device name listed in this FDA 510(k) record. The listed applicant is Wesley Jessen Corp.. It received FDA 510(k) clearance on 1996-01-04 under 510(k) number K954603. 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 DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT?

DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT is a medical device that received FDA 510(k) clearance on 1996-01-04. The listed applicant is Wesley Jessen Corp.. The 510(k) number is K954603.

When did DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT receive FDA 510(k) clearance?

DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT received FDA 510(k) clearance on 1996-01-04, under 510(k) number K954603.

Who is the listed applicant for DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT?

The FDA 510(k) record lists Wesley Jessen Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT?

The FDA product code for DURASOFT FRESHLOOK UV COLORS; DURASOFT 3 FRESHLOOK UV LITE TINT is LPL.

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Other records listing Wesley Jessen Corp. as applicant

K000439DURASOFT 2 (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 2 (PHEMFILCON A) SHERICAL ( HYDROPHILIC)C K994335PROSOFT (PHEMFILCON) SOFT (HYDROPHILIC) CONTACT LENS K993935DURASOFT 3 UV (PHEMFILCON A) OPTIFIT TORIC (HYDROPHILIC) CONTACT LENSES, DURASOFT 3 UV (PHEMFILCON A) SPHERICAL (HYDROPI K991000GENTLE TOUCH UV (NETRAFILCON A) SOFT CONTACT LENSES K991550FRESHLOOK BIFOCAL UV-ABSORBING (PHEMFILCON A) MOLDED SPHERICAL HANDLING TINT AND COLORED SOFT (HYDROPHILIC0 CONTACT LENS K982988PRECISION UV (VASURFILCON A)

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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.