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FDA 510(k)

IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS

K-Number: K974837 · 1998-07-06

ApplicantIgel Vision Care Pte , Ltd.
Decision Date1998-07-06
Product CodeLPL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS is the device name listed in this FDA 510(k) record. The listed applicant is Igel Vision Care Pte , Ltd.. It received FDA 510(k) clearance on 1998-07-06 under 510(k) number K974837. 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 IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS?

IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS is a medical device that received FDA 510(k) clearance on 1998-07-06. The listed applicant is Igel Vision Care Pte , Ltd.. The 510(k) number is K974837.

When did IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS receive FDA 510(k) clearance?

IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS received FDA 510(k) clearance on 1998-07-06, under 510(k) number K974837.

Who is the listed applicant for IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS?

The FDA 510(k) record lists Igel Vision Care Pte , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) CONTACT LENS?

The FDA product code for IGEL(R) 56 (HEFILCON C) SOFT (HYDROPHLIC) 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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Igel Vision Care Pte , 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.

K021907IGEL 55 TORIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEARK020855IGEL 55UV (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR,IGEL 55 UV MULTIFOCAL (METHAFILCON A) SOFTK984523IGEL 56 UV (HEFILCON C) SOFT (HYDROPHILIC) CONTACT LENS

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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