FDA 510(k)

SOFT (HYDROPHILIC) CONTACT LENSES

K-Number: K982774 · 1998-09-02

Decision Date1998-09-02

Product CodeLPL

Advisory CommitteeOP

DecisionSubstantially Equivalent

Device Summary

SOFT (HYDROPHILIC) CONTACT LENSES is the device name listed in this FDA 510(k) record. The listed applicant is Cl-Tinters. It received FDA 510(k) clearance on 1998-09-02 under 510(k) number K982774. 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 SOFT (HYDROPHILIC) CONTACT LENSES?

SOFT (HYDROPHILIC) CONTACT LENSES is a medical device that received FDA 510(k) clearance on 1998-09-02. The listed applicant is Cl-Tinters. The 510(k) number is K982774.

When did SOFT (HYDROPHILIC) CONTACT LENSES receive FDA 510(k) clearance?

SOFT (HYDROPHILIC) CONTACT LENSES received FDA 510(k) clearance on 1998-09-02, under 510(k) number K982774.

Who is the listed applicant for SOFT (HYDROPHILIC) CONTACT LENSES?

The FDA 510(k) record lists Cl-Tinters as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SOFT (HYDROPHILIC) CONTACT LENSES?

The FDA product code for SOFT (HYDROPHILIC) CONTACT LENSES is LPL.

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Other records listing Cl-Tinters as applicant

K010126PROSTHETIC, GELFLEX ALPHA, (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)K984259PROSTHETIC (POLYMACON) HYDROPHILIC CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED)

Related Devices (Code: LPL)

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.