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FDA 510(k)

LL BI-FOCAL, DAILY WEAR CONTACT LENS

K-Number: K971647 · 1997-07-15

ApplicantLombart Lenses, Ltd.
Decision Date1997-07-15
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LL BI-FOCAL, DAILY WEAR CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Lombart Lenses, Ltd.. It received FDA 510(k) clearance on 1997-07-15 under 510(k) number K971647. 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 LL BI-FOCAL, DAILY WEAR CONTACT LENS?

LL BI-FOCAL, DAILY WEAR CONTACT LENS is a medical device that received FDA 510(k) clearance on 1997-07-15. The listed applicant is Lombart Lenses, Ltd.. The 510(k) number is K971647.

When did LL BI-FOCAL, DAILY WEAR CONTACT LENS receive FDA 510(k) clearance?

LL BI-FOCAL, DAILY WEAR CONTACT LENS received FDA 510(k) clearance on 1997-07-15, under 510(k) number K971647.

Who is the listed applicant for LL BI-FOCAL, DAILY WEAR CONTACT LENS?

The FDA 510(k) record lists Lombart Lenses, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LL BI-FOCAL, DAILY WEAR CONTACT LENS?

The FDA product code for LL BI-FOCAL, DAILY WEAR CONTACT LENS is LPL.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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Other records listing Lombart Lenses, Ltd. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K961428SOFT-55 DAILY WEAR CONTACT LENSK941877LL-55 (METHAFILCON A) FOR DAILY WEAR

Related Devices (Code: LPL)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.K260507Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo PlusINTEROJO, Inc.K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact LensesPegavision CorporationK261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision CorporationK253885PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS; PUSCON WATER BALANCE-1DAY COLOR (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENSESGEO MEDICAL CO., LTD.K254269Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV toric (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens; Saview SH Optic 38 UV multifocal (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact LensSt. shine Optical Co., Ltd.

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.

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