FDA 510(k)

RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT

K-Number: K962957 · 1996-10-01

Decision Date1996-10-01

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT 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 1996-10-01 under 510(k) number K962957. 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 RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT?

RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT is a medical device that received FDA 510(k) clearance on 1996-10-01. The listed applicant is Wesley Jessen Corp.. The 510(k) number is K962957.

When did RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT receive FDA 510(k) clearance?

RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT received FDA 510(k) clearance on 1996-10-01, under 510(k) number K962957.

Who is the listed applicant for RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT?

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 RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT?

The FDA product code for RURASOFT 2 FRESHLOOK COLORS; DURASOFT 2 FRESHLOOK LITETINT 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.