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FDA 510(k)

SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS

K-Number: K013649 · 2001-12-26

ApplicantSauflon Pharmaceuticals, Ltd.
Decision Date2001-12-26
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Sauflon Pharmaceuticals, Ltd.. It received FDA 510(k) clearance on 2001-12-26 under 510(k) number K013649. 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 SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS?

SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS is a medical device that received FDA 510(k) clearance on 2001-12-26. The listed applicant is Sauflon Pharmaceuticals, Ltd.. The 510(k) number is K013649.

When did SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS receive FDA 510(k) clearance?

SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS received FDA 510(k) clearance on 2001-12-26, under 510(k) number K013649.

Who is the listed applicant for SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS?

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

What is the FDA product code for SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS?

The FDA product code for SAUFLON 55 UV SOFT (HYDROPHILIC) CONTACT LENS is LPL.

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Other records listing Sauflon Pharmaceuticals, 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.

K130342SAUFLON CLARITI (SOMOFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKERK130331SAUFLON CLARITI 1 DAY (SOMOFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENS WITH UV BLOCKERK130734SAUFLON MULTIPURPOSE SOLUTIONK052832SAUFLON NEW DAY (METHAFILCON A) SOFT (HYDROPHILIC) DAILY DISPOSABLE CONTACT LENSESK052809SAUFLON FLAT COLOURED LENS CASEK033656SAUFLON FLAT LENS CASE/SAUFLON 2003 BARREL LENS CASE

View all 11 devices →

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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